Total 9 Director/C-Level quality control engineer job vacancies in Quality Assurance / Control category in Australia

The Director, QRM, Global QMS, R&D & PV QA is accountable for establishing, governing, and continuous advancing a robust, science- and risk-based Quality Risk Management framework across R&D & Clinical Safety Pharmacovigilance, Medical Affairs and associated quality system.

This role serves as the global QA authority for quality risk management, providing independent oversight, governance, and strategic leadership to ensure that quality risk are proactively identified, assessed, controlled, communicated, and reviewed in alignment with ICH Q9 (R1), ICH Q10, company quality standards, and global regulatory expectations. The incumbent ensures that functional and cross-functional risk management activities are consistent, proportionate, traceable, inspection-ready and appropriately escalated within the QMS and enterprise risk management structures.

JOB DESCRIPTION

1.    Global Quality Risk Management Framework

a.   Lead the design, implementation, governance and continuous evolution of the global Quality Risk Management (QRM) framework across R&D, Pharmacovigilance, Medical Affairs, and associated quality systems, in alignment with ICH Q9 (R1), ICH Q10, and applicable global GxP regulations.

b.    Establish and maintain standardized risk assessment methodologies, tools, templates, and governance models within the QMS.

c.     Define, govern and maintain risk assessment principles, risk acceptance criteria, and quality risk posture for R&D & PV and MA, ensuring alignment with enterprise risk management and global quality strategy.

d.    Own the multi-year QRM roadmap, including capability maturity, systems enablement, and integration with broader QMS and business processes.

2.    Risk Identification, Assessment & Independent QA Oversight

a.    Provide independent QA oversight and expert leadership for quality risk identification, assessments, control, communication, and review activities across the end-to-end product and system lifecycle.

b.    Oversee and challenge quality risk assessment related to, but not limited to :

         i.     RDPVMA processes and systems 

         ii.   Vendor, outsourcing and third-party activities

         iii.   Change management and transformation initiatives

         iv.   Inspection readiness, compliance, and systematic quality risks

c.     Ensure quality risks are scientifically justified, proportionate, traceable and inspection-ready, with clear linkage to QMS records, mitigation actions, and management decisions.

d.    Exercise QA authority to escalate, challenge, and influence decisions where risks are not adequately mitigated, understood, or appropriately accepted.

3.    Governance, Integration & Management Review

a.    Establish and lead quality risk governance structures, including escalation pathways and decision forum for critical, cross-functional or systemic risks.

b.    Embed quality risk management outputs into key QMS processes, including Quality Event (QE) Management, CAPA, change control, supplier oversight, audit management and Quality Management Review.

c.     Lead and shape risk-based inputs to management reviews and executive quality governance, providing clear visibility of risk trends, emerging issues, and mitigation effectiveness.

d.    Ensure alignment and traceability between functional risk registers, QMS risk records, and enterprise-level risk reporting.

4.    Digital Enablement, Metrics & Continuous Improvement

a.    Own and evolve digital QRM tools, dashboards, and analytics to support proactive, data-driven risk identification, trending, escalation, and decision-making.

b.    Define and monitor QRM performance indicators and effectiveness metrics, ensuring meaningful insights for senior management and continuous inspection readiness.

c.     Drive continuous improvement of quality risk management practices based on audit outcomes, inspection findings, key trends, and performance data.  

5.    Regulatory Intelligence, Audit & Inspection Readiness

a.    Monitor, interpret, and translate evolving global regulatory expectations and inspection trends (e.g. ICH Q9 (R1), regulatory and inspection focus area) into QRM strategy, standards and training.

b.    Provide leadership and oversight for risk-based audit preparation, inspection readiness, and regulatory interactions related to quality risk management.

c.     Support and guide organizational responses to inspection observations, audit findings, and regulatory commitment where quality risk management is impacted.

6.     Cross‑Functional & Third-Party Risk Oversight

a.    Partner closely with global stakeholders across R&D, Clinical Safety Pharmacovigilance, Medical Affairs, Regulatory Affairs, IT, Procurement, and vendor Quality to ensure effective, consistent, and compliance implementation of quality risk management.

b.    Provide governance and QA oversight of third party and vendor risk management programs, ensuring alignment between internal quality expectation and external partner practices.

c.     Influence cross-functional and matrix teams to embed risk-based thinking into strategic and operational decision-making.

7.    Training & Capability Building & Quality Culture

a.    Act as global quality risk management thought leader and champion, strengthening organizational capability through targeted training, coaching, and mentoring.

b.    Develop and deliver QRM training curricula to ensure consistent understanding and practical application of risk management principle across regional and functions.

c.     Promote and reinforce a strong quality culture that emphasizes proactive risk identification, transparency, prevention and accountability.

JOB REQUIREMENTS

- Bachelor’s degree in Life Sciences, Pharmacy, Medicine, Engineering, or a related scientific or technical discipline.

- Advanced degree (PhD, PharmD, MSc, MPH, MBA) or equivalent professional experience in a regulated pharmaceutical or biotechnology environment is preferred.

- 8–12+ years of progressively responsible experience in pharmaceutical quality, compliance, quality risk management, or regulated GxP environments, with demonstrated experience operating at a global and cross-functional level.

- Proven track record in establishing, governing and sustaining quality risk management framework within a global Quality Management System, including practical application of ICH Q9 (R1) and integration with ICH Q10.

- Strong experience providing independent QA oversight across R&D and Pharmacovigilance and Medical Affairs with exposure to multiple GxP domains (e.g. GCP, GVP, GLP, and GxP computerized systems).

- Demonstrate experience supporting regulatory inspections, health authority interactions, internal and external audits, including risk-based reparation, issue management, and inspection response.

- Experience partnering with senior stakeholders in global, matrixed organizations, influencing without authority and balance compliance, risk and business objectives.

- Experience overseeing or governing third-party, vendor, and outsourcing risks, including alignment of internal quality standards with external partner practices.

- Exposure to digital quality system, risk analytics, metrics, or dashboards is highly desirable.  

- Deep expertise in quality management principles, risk-based decision making, and proportional application of controls in regulated environments.

- Strategic and system-level thinking with the ability to translate regulatory expectations and inspection trend into practical, sustainable QRM practices.

- Strong analytical, critical thinking, and problem solving skills, with sound judgement in complex or ambiguous risk scenarios.

- Demonstrate ability to influence, challenge, and drive alignment across functions, regions, and senior leadership levels while maintaining QA independence.

- Clear, concise, and inspection‑ready communication skills, both written and verbal.

- High level of accountability, integrity, and attention to detail, with ability to balance compliance rigor with business pragmatism.

- Strong capability in coaching, mentoring, and capability building, fostering a proactive quality and risk-aware culture.

- A globally aligned, inspection‑ready Quality Risk Management framework embedded within the Global QMS and consistently applied across R&D, Pharmacovigilance, Medical Affairs, and associated activities.

- Standardized, scalable quality risk management methodologies, tools, templates, and governance models that support proportional, science‑based, and risk‑based decision‑making.

- Clearly articulated and traceable quality risk assessments, risk registers, and mitigation plans, integrated with core QMS processes and enterprise risk management structures.

- Executive‑level risk insights, metrics, and trend analyses supporting Quality Management Review, senior leadership decision‑making, and continuous improvement.

- Digitally enabled QRM dashboards, analytics, and reporting that provide transparency, early risk detection, and sustained inspection readiness.

- Robust, inspection‑ready risk governance evidence supporting regulatory inspections, audits, and health authority interactions.

- Strengthened organizational capability and quality culture, demonstrated through consistent application of risk‑based principles, effective training, and proactive risk awareness across global stakeholders.

- Effective third‑party and vendor risk oversight, ensuring alignment between internal quality expectations and external partner practices.

A leading global pharmaceutical organization is seeking aDirector of Quality Risk Management (QRM) to lead and evolve a best-in-class,science-driven risk framework across R&D, Pharmacovigilance, and MedicalAffairs.

This is a high-impact leadership role with globalvisibility, shaping how risk-based decision-making is embedded across theenterprise and ensuring alignment with ICH Q9 (R1), ICH Q10, and global GxPstandards.

Your main responsibility will be to:

• Lead the design and governance of a global QRM framework across R&D and PV
• Provide independent QA oversight on risk identification, assessment, and mitigation
• Drive risk-based decision-making across cross-functional stakeholders
• Embed QRM into core QMS processes (CAPA, audits, change control, vendor management)
• Deliver executive-level risk insights, dashboards, and trend analytics
• Support inspection readiness, regulatory interactions, and audit responses
• Champion quality culture and capability building across global teams

To be shortlisted for the role, you would ideally come with:

• 10+ years in GxP Quality / QA / Compliance within pharma/biotech
• Strong experience in Quality Risk Management frameworks (ICH Q9)
• Exposure across R&D, Pharmacovigilance (GVP), Clinical (GCP)
• Proven ability to operate at a global, cross-functional leadership level
• Experience supporting regulatory inspections and audits
• Strong stakeholder management with the ability to influence without authority
• Experience with digital QMS, risk analytics, or dashboards is a plus

AC
Reg. No. R1110770
BeathChapman Pte Ltd
Licence no. 16S8112

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us?

The Director, Quality Assurance is primarily responsible for developing and implementing strategies for quality oversight across all Affiliate sites within Alcon's Quality & Regulatory Affairs. You will ensure compliance with quality standards, manage quality events, and oversee complaint handling.

Specifics Include:

• Lead and direct teams to develop and implement strategies for departmental success and alignment with company goal
• Ensure compliance with quality standards and drive continuous improvement initiatives
• Manage departmental resources and make key decisions
• Guide non-conformance investigations with a structured approach to root cause analysis and problem-solving
• Lead audit preparation and manage external audits by Health Authorities and Notified Bodies
• Oversee all Quality-related activities at the country level, ensuring compliance with regulatory standards and global requirements
• Oversee quality control activities for finished products and handle product complaints
• Develop and oversee processes for an effective Quality System, includingself-inspections, supplier qualifications, corrective and preventive action (CAPA) processes, and Standard Operating Procedure (SOP) compliance
• Promote a strong Quality Culture and work closely with commercial partners and leadership teams to drive compliance as a strategic business platform
• Ensure compliance with market authorization, Good Manufacturing Practice(GMP), International Organization for Standardization (ISO) 13485, Good Distribution Practice (GDP), and local requirements
• Review and approve documentation for medicinal products and medical devices
• Ensure Good Practice (GxP) suppliers are qualified and monitored, and manage market actions
• Adhere to GxP regulations by following SOPs, maintaining accurate documentation, and completing required training
• Contribute to the overall compliance of the organization through individual job requirements
• Lead quality reviews with leadership teams, oversee key quality indicators at both country and regional levels, ensure each country’s quality plans align with regional and global standards, and managing escalations to the Global Quality Compliance function
• Oversees monthly quality performance by tracking and submitting KQI metrics, managing quality risk assessments, preparing reports for the CSCQ Head, and maintaining ongoing surveillance to support business continuity
• Oversee the end‑to‑end complaint handling operations, including timely intake, assessment, follow‑up, and routing of technical complaints and Adverse Events for all Alcon medical device products, ensuring compliance with local and international regulatory requirements
• Drive a strong quality and compliance culture across the region by promoting best practices, ensuring consistent application of complaint handling processes, and supporting continuous improvement of quality systems
• Lead and develop the complaint handling team, providing guidance on investigations, overseeing case triage, and managing escalations such as product replacements and refund requests to ensure efficient and accurate resolution
• Ensures strong people and capability development by driving talent development and succession planning, managing direct reports’ performance and compliance, overseeing training completion, and providing ongoing leadership and mentorship to the team
• This role also requires regular regional travel to support country teams, oversee activities, and ensure consistent implementation of quality standards
  

Education:                      Bachelor’s Degree in Life Sciences, Pharmacy, Engineering or other scientific discipline

Languages:                     English Proficiency

       Knowledge/ Fluency of at least one other language preferred

Experience:

• Minimum 15 years of experience in Quality Assurance, 10 years of people leadership in the medical device industry with people management experience in a matrix environment.
• Experience working in a multinational company or across multiple countries in the APAC region.
• Proven track record of developing and implementing quality assurance strategies and programs.
• Strong understanding of regulatory requirements and industry standards related to quality assurance (e.g., ISO 9001, ISO 13485, GMP, QSD and other industry standards that may apply).
• Excellent leadership and communication skills, with the ability to motivate and inspire teams to achieve quality objectives.
• Analytical mindset with strong problem-solving skills, able to lead root cause analysis and CAPA initiatives.
• Broad understanding of global expectations of Health Authorities in the GxP regulated area.
• Exposure to manufacturing operations and /or quality assurance, country organizations or commercial operations.
• Knowledge and experience in forecasting software and demonstrated proficiency in Microsoft suites.

Why join Alcon?

- Join a global leader with a rich history of innovation and excellence in eye care.

- Be part of a collaborative and supportive team culture that values diversity and inclusion.

- Enjoy a competitive compensation package and opportunities for career advancement.

- Make a meaningful difference in the lives of patients worldwide by contributing to cutting-edge advancements in eye health.

If you're ready to take the next step in your career and lead a dynamic team towards success, we want to hear from you! Apply now and join us in shaping the future of eye care at Alcon.

Alcon Careers

See your impact at alcon.com/careers

This leadership role is responsible for shaping and driving quality excellence across the entire new product development lifecycle—from early concept through industrialisation and customer deployment. The position partners closely with engineering, operations, and commercial teams to ensure new products are delivered with high reliability, scalability, and customer satisfaction across global manufacturing footprints.

Responsibilities

• Define and evolve quality frameworks and governance models for new product development and introduction
• Establish and deploy quality plans, control strategies, and risk management practices aligned with design intent and manufacturing readiness.
• Lead quality activities throughout prototype builds, pilot runs, ramp-up, and customer launches, including internal and external sites
• Drive structured risk identification, mitigation planning, and lessons‑learned integration within NPD programs
• Build and sustain quality systems that transition seamlessly from development into mass production
• Own reliability, validation, and qualification strategies to ensure products meet performance and lifetime expectations
• Partner with cross‑functional leaders to align on quality standards, customer requirements, and delivery commitments
• Provide senior management with regular insights into quality performance, risks, and improvement actions
• Champion data-driven decision making by leveraging digital tools, analytics platforms, and integrated systems
• Develop, coach, and lead a geographically distributed quality organisation supporting multiple product lines
• Continuously improve workflows, resource planning, and operational efficiency within the NPD quality function
• Act as a key interface for strategic customers, manufacturing sites, and critical stakeholders on quality-related topics

Requirements

• Bachelor’s degree or higher in Engineering, Materials Science, Physics, or a related technical discipline
• Extensive experience in complex manufacturing environments, with strong exposure to new product introduction
• Solid understanding of quality management systems and industry standards (e.g. ISO, IATF or equivalent)
• Demonstrated leadership of multi-site or cross-regional teams within high-precision or advanced technology industries
• Strong background in risk assessment, root cause analysis, and structured problem-solving methodologies
• Track record of influencing senior stakeholders and driving alignment across functions
• Comfortable operating in fast-moving environments with shifting priorities
• Proficient in using digital tools and data platforms to support quality analytics and process optimisation
• Willingness to travel regularly to manufacturing and customer locations

What you need to do now

If you're keen on pursuing this exciting opportunity, please send a copy of your CV to shania.herman@hays.com.sg for confidential discussion.
EA Reg Number: R23117025
EA Licence Number: 07C3924
Company Registration No. 200609504D

**Final designation will depend on candidate’s profile, experience, and selection outcome**

Role Purpose:

The Associate Director / Senior Manager - Quality is responsible for leading the quality control portfolio while driving studio-wide process excellence, operational efficiency, and strategic transformation initiatives.

This role also combines project management, process transformation, and operational governance to ensure high-quality delivery across multiple projects in specialized teams (TSD) & Mobile. The position partners closely with QC Leadership, Production teams, and WWQC stakeholders to standardize processes, optimize workforce utilization, improve delivery effectiveness, and embed a culture of continuous improvement and data-driven decision-making.

Key Responsibilities:

1. QC Program & Portfolio Management

• Manage a portfolio of QC projects across Specialized teams (TSD) & Mobile.
• Oversee planning, execution, and delivery of QC programs ensuring quality, schedule, and scope objectives are met.
• Supervise and guide QC Project Managers, Project Leads, and testing teams.
• Conduct periodic project reviews with QC leadership to evaluate project performance and risk.
• Monitor project KPIs and performance indicators to ensure quality and delivery effectiveness.
• Validate key project deliverables including test strategies, test plans, and automation roadmaps.

2. Strategic Leadership & Transformation

• Drive large-scale transformation initiatives aligned with studio and global QC strategies.
• Partner with QC leadership to define and execute studio-level strategic roadmaps.
• Identify opportunities to improve testing frameworks, tools, processes, and delivery models.
• Adapt QC strategies to evolving game development trends such as GAAS and live operations.
• Interface with WWQC leadership, production teams, and studio management to ensure strategic alignment.

3. Process Excellence & Continuous Improvement

• Lead process re-engineering and simplification initiatives across QC and delivery functions.
• Standardize QC and delivery workflows through defined process journeys and SOPs.
• Identify and prioritize high-impact improvement opportunities across operations.
• Apply Lean Six Sigma methodologies to improve efficiency, quality, and productivity.
• Act as a subject matter expert and mentor on process improvement frameworks.

4. Operational Effectiveness & Workforce Optimization

• Optimize resource planning and workforce allocation across QC projects.
• Anticipate future talent needs based on evolving project and business requirements.
• Partner with HR and Talent Acquisition to address skill gaps and staffing requirements.
• Promote organizational efficiency through pyramid optimization and talent development strategies.
• Support the drive of learning and development initiatives including upskilling and cross-skilling programs.

5. Governance, Metrics & Data-driven Decision Making

• Establish and maintain studio-wide governance frameworks for QC projects.
• Define and track KPIs to measure quality, operational efficiency, and delivery performance.
• Drive adoption of data analytics, dashboards, and reporting mechanisms.
• Provide actionable insights to leadership for strategic and operational decision making.

6. Stakeholder Management & Communication

• Develop communication frameworks to ensure alignment on QC strategy and project execution.
• Collaborate closely with Production, WWQC teams, and studio leadership.
• Provide regular updates and reports to executive leadership on project status and strategic initiatives.
• Facilitate cross-studio collaboration on global QC initiatives and improvement programs.

7. Change Management & Culture Building

• Lead change initiatives to implement new processes, tools, and operational models.
• Promote a culture of innovation, continuous improvement, and quality excellence.
• Organize initiatives such as ideathons and improvement programs to encourage innovation.
• Drive adoption of data-driven problem solving across teams.

8. Automation & Innovation

• Support integration of automation frameworks into QC workflows.
• Collaborate with R&D and global QC teams to pilot and implement new testing technologies and methodologies.
• Continuously explore innovative approaches to improve testing effectiveness and efficiency.

9. People Leadership:

• Lead and mentor managers, leads, and testing teams.
• Provide coaching, career development, and performance management support.
• Identify and develop high-potential talent within the TSD and Mobile projects.
• Foster a collaborative, high-performance team culture.

Key Accountabilities:

Formulation and execution of a viable, results-oriented strategy for assigned area

• Establish, promote and sustain a vision, mission, strategic and policies for quality assurance; communicate them to team, along with internal and external clients in a spirit of shared partnership
• Oversee the coordination and hosting of cross-functional Sponsor Audits and Regulatory Inspections, as well provide management support to QA staff for Sponsor Audits and Regulatory Inspections
• Implement yearly risk-based audit plan for the area of responsibility, and continuously evaluate risk and adjust audit plan accordingly, coordinate with peers and ensure execution of the annual audit plan
• Champion and support compliance with applicable regulations, laws, Parexel procedures and policies
• Promote a vision and action for compliance and standards across the company, fostering cooperation, globalization and positive communication
• Articulate issues and concerns to senior / executive management in a constructive, clear and actionable manner; using metrics and data
• Works closely with Sr. Management to manage current issues and anticipate upcoming auditing needs
• Effectively lead and manage crisis situations, providing direction and solutions
• Act as Escalation Point within the Organization, as well as with external clients / regulatory authorities for any major compliance concerns, providing direction and solutions. Manage the assigned internal QA team, systems and process; coordinating with peers
• Actively manages performance consistent with the strategy/plan
• Anticipate problems, recognizing obstacles and seeking opportunities
• Delegate effectively, focusing on results, allowing others to learn and grow in a supportive environment
• Actively implement and support the use of Audit Management application and related metrics
• Motivate others through personal leadership and credibility
• Support the recruitment, supervision, training and mentoring of the QA team
• Work both independently, but in coordination and in conjunction with peers
• Provision of management support to team, including prioritization of tasks, evaluation and monitoring of quality and timeliness of work performed
• Provide technical support and problem resolution for the team, as needed
• Think and analyze issues globally, not only regionally
• Ensure training and development of team
• Build, develop, and maintain good working relationships with internal and external customer groups
• Develop and implement a budget for assigned area; communicating needs and changes with appropriate groups
• Be a role model, sharing yourself, your knowledge and ideas with others
• Build character in the team and company through actions and intentions
• Maintain relevant knowledge of appropriate GxP requirements and developments as they impact Parexel
• Maintain and / or develop records / documents, as required to meet the needs of the team, along with those of internal and external clients
• May serve as a member of industry association boards, task forces and committees and / or as chairperson or officer of one or more professional associations. Contributes expertise to professional societies, academic, or other similar groups influential in his /her area of expertise

Work closely with QA Senior Management

• Aligns with Senior Management to manage current issues and anticipate upcoming auditing needs. Develop and implement a budget for assigned areas; communicating needs and changes with appropriate groups

Build and maintain relationships

• Build, develop, and maintain good working relationships with internal and external customer groups Work well in team environment

Perform other quality related tasks or projects as assigned

• Perform other quality related tasks or duties as assigned by QA management
• Travel internationally on assignments as required. Travel time could be up to approx. 60%.

Skills:

• Demonstrate competence in quality assurance and management, emphasizing continuous improvement
• Knowledge of models and trends in quality assurance, ‘quality’ and management
• Ability to represent a positive attitude, recognizing it as a choice which determines actions and influence
• Ability to discern where to place efforts / actions, so it adds the greatest value and maximum impact
• Demonstrated ability to successfully manage multiple teams and multiple projects
• Ability to develop relationships with a culturally diverse group of key stakeholders within Parexel, the client’s business, and regulatory authorities
• Excellent interpersonal, verbal and written communication skills, including experience in making presentations at conferences, meetings and training sessions
• Experience with Microsoft based applications and ability to learn internal computer systems
• Willingness to work in a matrix environment and to value the importance of teamwork
• Ability to work flexibly and adjust to changing priorities and unforeseen events
• Diplomatically address sensitive issues confidentially and professionally
• Excellent knowledge of, and working experience with, relevant national / international regulations
• Analyze complex situations / issues and effectively communicate situations / issues, along with potential recommendations
• Work independently and consistently in a fast-paced environment
• Ability to train and coach team

Knowledge and Experience:

• Proven experience in pharmaceutical quality assurance, including international quality assurance, substantial experience in the GxP area, with demonstrable track record of establishing effective audit functions and teams; and with proven experience in managing people and projects

Education:

• 15+ years’ experience in quality assurance or relevant area, including 5 years of applicable GxP auditing.
• 7+ years managing a team
• Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
• Strong command of written and spoken English language, local language proficiency as required

Who we are

We live and breathe audio. We are driven by the passion to create audio solutions that make a difference. The business with consumer devices such as headphones, soundbars and speech-enhanced hearables is now operated by Sonova Holding AG under the license of Sennheiser.  

With the well-known Sennheiser brand, the company stands for premium quality in the field of audio products. In order to remain among the best in its field, Sonova Consumer Hearing is always on the lookout for outstanding talent for the Sennheiser brand. The company is headquartered in Hannover, Germany, with approximately 600 employees worldwide.

Senior/Director, Quality

We are seeking an experienced and strategic leader to head our Qualification and Quality Management function. This role is responsible for defining and driving end-to-end qualification strategies, overseeing the global Quality Management System (QMS) in alignment with ISO standards, and ensuring robust product and process quality across internal operations and external manufacturing partners.

The successful candidate will lead a global team and work cross-functionally with R&D, operations, and suppliers to ensure manufacturing readiness, production excellence, and continuous improvement throughout the product lifecycle. This role also serves as the primary quality interface for contract manufacturers, particularly in Asia, ensuring compliance with regulatory, customer, and industry requirements.

This is a high-impact leadership position that combines strategic oversight with operational execution, playing a critical role in enabling successful product launches, scalable production, and sustained quality performance.

Job responsibilities:

• Define and execute global qualification and production quality strategies aligned with business and operational goals.
• Lead, develop, and inspire a global team, fostering a culture of quality, accountability, and continuous improvement.
• Establish standardized frameworks, methodologies, and governance models across regions and sites.
• Own and maintain the global QMS in compliance with ISO standards.
• Lead certification and surveillance audits, ensuring timely closure of findings.
• Drive corrective and preventive actions, management reviews, and continuous improvement initiatives.
• Ensure robust documentation, process controls, and regulatory compliance across the organization.
• Oversee qualification processes for new product introductions, transfers, and changes.
• Ensure effective process validation, manufacturing readiness, and production release.
• Govern qualification documentation, test protocols, validation reports, and traceability.
• Integrate field feedback and lessons learned into qualification standards.
• Partner with manufacturing and operations teams to ensure stable, capable production processes.
• Embed manufacturability and quality requirements early in design and development.
• Support product ramp-up, transfers, and scale-up activities.
• Own quality performance for externally manufactured products.
• Act as the key quality interface for Asian contract manufacturers.
• Lead supplier qualification, audits, and development initiatives.
• Ensure supplier compliance with ISO 9001 and customer/regulatory requirements.
• Provide escalation support and drive continuous improvement with suppliers.
• Collaborate with R&D, project management, regulatory, and operations teams to integrate quality throughout the product lifecycle.
• Act as a trusted advisor on quality and qualification matters.
• Identify and mitigate risks related to product quality, supplier capability, and regulatory compliance.
• Develop and implement risk mitigation and contingency plans.
• Engage with customers to understand and align on quality and compliance expectations.
• Ensure customer requirements are embedded into QMS and qualification processes.
• Define and track KPIs for qualification, production quality, supplier performance, and compliance.
• Provide regular reporting and strategic insights to senior leadership.

Pre-requisites:

•  Technical degree (BA, Master, Ingenieur, PhD).
• 8-10 years relevant experience in product and process qualification of which 5 years with leadership responsibility.
• Broad technical knowledge in the respective field.
• Deep knowledge of quality processes.

• Product development experience.
• Excellent communication and interpersonal skills.
• Structured and solution-oriented thinking.
• Very good problem-solving skills.
• Hands-on mentality.
• Ability to drive topics with the team and get things done.
• Good strategic thinking skills.
• Very high leadership skills or the respective potential.
• Proven ability to empower and motivate people and teams.
• Continuous improvement, agile mindset.
• Good knowledge on tools and methods to organize and structure agile teams and agile/non-agile work tasks.
• Audio/headphone product development experience is and added advantage.

• Establishes Quality and Reliability standards by studying Product and Consumer requirements with other members of Management as well as with Operations’ personnel.
• Establishes input material standards through engagement with manufacturing and engineering personnel; conferring, coaching and negotiating with suppliers; devising testing methods and procedures to ensure conformance.
• Establishes In-process Product and Process monitoring standards by understanding Product, Process & Customer needs; devising testing methods and procedures; enforcing compliance.
• Establishes standards for the disposition of finished product by devising evaluation tests, methods and procedures.
• Establishes rework standards, where applicable by devising inspection and physical testing methods and procedures.
• Establishes Product Quality documentation system by drafting and updating Quality Assurance procedures.
• Maintains Product Quality by enforcing Quality Assurance policies and procedures as well as applicable regulatory requirements.
• Collaborate with members of Management to develop and deploy New Product Introduction, Engineering Design, Manufacturing and Training methods targeting Excursion-free Ramp.
• Collates Product and Process Quality Reports for analyzing and summarizing the information and tracking trends to trigger timely Corrective/Preventive/improvement initiatives thereby preventing Excursions.
• Completes Quality Assurance Operational requirements by scheduling and assigning employees; following up on work results.
• Maintains Quality Assurance Organization structure by Recruiting, Selecting, Orienting and Training employees.
• Motivates and Retains Quality Assurance Staff by Coaching, Counseling, and Disciplining employees, where needed; Planning, Monitoring and Appraising outcome from the business Objectives’ perspective as strategized by the Executive Management of the company.
• Maintains Professional and Technical Knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
• Achieves financial objectives by preparing the Quality Assurance budget; scheduling expenditures; analyzing variances; initiating corrective actions to address gaps, if any, in a timely manner.
• Works together with the Team with Passion to achieve targeted Objectives.
• Ensures Integrity and be the Voice of the Plant and Voice of the Customers protecting interests of both parties

Required Experience and Qualifications (Required knowledge, skills and experience---however acquired):

• Degree in Electrical/Electronics/Mechanical/Chemical Engineering or Material Physics
• More than 10 years experience in Packaging, Test, Wafer Sort, Wafer Bumping and associated Backend Operations out of which at least 5 years in managerial position.
• Preferably experienced in a multi-cultural environment with exposure to Global customer-base.
• Knowledge of Quality tools such as 8D systematic problem solving methodology, FMEA, statistical tools such as JMP is desirable.
• Good understanding of ISO9000, TS16949, ISO14001 and OHSAS18001 besides Regulatory requirements such as ROHS, REACH, Conflict Free sourcing initiatives etc.

JOB REQUIREMENT / RESPONSIBILITIES

The main responsibilities of the Group Quality Director under the leadership of the CEO is to formulate and implement the company's quality strategy, quality objectives, quality policies and quality systems, and to be fully responsible for the company's quality management, improve customer satisfaction, and realize the company's operations Strategic objectives.

Responsibility:

1. Responsible for the formulation of the overall quality policy, overall responsibility for quality management, setting and maintaining quality goals.
2. Implement and optimize the quality management system, prepare medium and long-term quality plans, strengthen quality target management, organize personnel to review it to ensure its effective control and operation, and ensure the realization of quality targets and vision.
3. Host major quality special meetings, coordinate the cooperation of various departments, and carry out major quality improvement and cost reduction projects.
4. Strengthen systematic training on quality tools, concepts and methods such as 6Sigma, improve application capabilities, and promote improved problem-solving timeliness.
5. Establish and maintain customer satisfaction goals, review quality control policies, procedures, systems, and operating specifications, and supervise the implementation of quality policies and systems.
6. Implement product audits, effectively monitor process quality indicators, promote the improvement and enhancement of process quality, and ensure that products put into production and mass production meet delivery quality targets.
7. Effectively promote the improvement of after-sales quality problems and the resolution of customer complaints and improve customer satisfaction.
8. Responsible for strengthening and consolidating the firewall (FVMI/CSL1/GP12/IPQC), internally blocking the outflow of defective products, and reducing the company's external quality costs.
9. Promote the improvement of quality management capabilities of all employees, organize, plan, and supervise the implementation of improvement education and training, and conduct effect evaluation and verification.
10. Regularly provide quality data reports, analysis, and improvements to provide basis for decision-making.
11. Carry out the company's safety production tasks and ensure the continuous improvement of 6S conditions within the jurisdiction.

KEY REQUIRED EXPERIENCE, SKILLS AND ABILITY

1. Must have deep knowledge and experience of regulatory requirements for Medical and operational world class standards
2. Must have QMS experience for medical device manufacturing
3. Desired experience and knowledge of Automotive Standards and Practices
4. Experience as a Lead Auditor
5. More than eight years of experience in manufacturing quality overall management.
6. Proficient in ISO/TS systems such as FDA21CFR, IATF, VDA6.3, ISO9001, ISO14001, ISO13485, TS16949, etc.
7. Proficient in process control/product control/process improvement tools such as SPC, MSA, FMEA, DOE, 6Sigma, etc.
8. Familiar with relevant systems and standards of the automotive industry, with good understanding and judgment
9. Have strong statistical ability and logical thinking ability, and strong quality analysis and reporting ability.
10. Have good internal and external communication and coordination skills.
11. Ability to communicate fluently in spoken English.
12. Able to accept domestic and overseas business assignments.