Total 254 procurement manager job vacancies in Quality Assurance / Control category in Indonesia

PURPOSE

The Quality Manager is leading ARU on Quality related processes and task in compliance to Chorus reference system, customer and regulatory requirements.

JOB RESPONSIBILITIES:

Strategic Leadership

• Sets quality key performance indicators for the team to achieve are met.
• Ensures there are enough resources within Quality team to meet internal Quality core activities.
• Leads quality initiatives and be an active member in all relevant Continuous Improvements projects within the company to advice on Quality/Compliance matters.
• Interface with quality departments of different business units to share best practices and lesson learnt.

Quality Management

• Drives and engages all staff to promote Quality culture and ethics within the organization, through training programs and etcetera.
• Facilitates and leads customer and regulatory audits or assessments effectively.
• Leads the setup of the QMS in accordance to applicable standards (AS9110) and achieve compliance in alignment with Part 145 (ARU).

Quality Assurance Standards

• Creates a yearly internal audit plan in accordance to AS9110 and Part-145 (ARU)requirement, and ensure that the audits are executed and closed within stipulated period.
• Ensures all Quality Manual (AS9110 requirements) and Maintenance Organization Exposition are updated and approved by various Civil Aviation Authorities.
• Participates in reviewing relevant supplier VWI (Vendor Work Instruction) that meets the requirement of the company’s scope of work as per regulations.
• Ensures the conformity of delivered products and relevant documents released are as per requirements.

Information Security

• Plan, organize and support educational activities to promote the Cybersecurity culture.
• Identify the hazards and risks involved in current practice, and evaluate the effectiveness of the mitigation actions.
• Oversee the collection and analysis of quality data to develop long-term quality strategies and programs

Other Responsibilities

• Ensures all test software and test equipment/bench are protected from cybersecurity threats through internal audits and know-how
• Execute Internal Audits with Quality requirements from IA9110 standard.
• Adapt Part IS and SMS as part of IA9100 implementation in the QMS.
• Promote prevention of counterfeit parts in the QMS through Awareness and Training

MINIMUM REQUIREMENTS

Education 

Degree/ Diploma in Quality, Quality Management or Mechanical Engineering or Electrical Engineering or Electronic Engineering or Equivalent

Experience 

• Minimum 8 years of experience in Avionics Workshop Production or Maintenance Environment/ Electronics Workshop / Mechanical Workshop or production.
• Minimum 8 years of Quality Management and Auditing experience.
• Experienced in Management of Quality Team in MRO capacity
• Experienced in Procedural and Process developments.
• Lead Auditor Trained

Your Job

As the Sr / Manager, Quality, you will be responsible for the overall quality management of Molex Singapore. You will lead initiatives to improve quality culture, risk management, and drive continuous QMS (Quality Management System) improvements. This role requires collaboration across multiple functions including operations, engineering, procurement, and customer quality to meet and exceed customer expectations.

Our Team

You will lead a dedicated Quality team consisting of supervisors, engineers, technicians, and inspectors supporting the Datacom and Specialty Solution division. The team works closely with internal stakeholders such as product design, manufacturing, sourcing, and sales, as well as external customers and suppliers.

What You Will Do

• Identify areas of improvement within the quality group and develop strategies. Quality initiatives would involve functions such as operations, engineering, procurement, etc. to seek collaborative efforts to meet quality needs
• Drive more robust risk assessment and decision-making processes in the plant on the foundation of Quality Culture development
• Collaborative efforts with Advance Quality Planning group to ensure smooth and effective launches for key products/projects
• Continuously drive plant QMS improvement by implementing strategies and initiatives based on the direction from global and divisional QMS. Complete all 3rd party audits with minimum findings
• Focus on customer satisfaction in quality area including the effectiveness and responsiveness of problem-solving. Execute Molex QN procedure to address customer complaints, continue to challenge Quality of 8D report with tool utilization and communication with customers in timely and effective manner.
• Effectively manage customer audits/visits to Molex Singapore and ensure we are the choice of supplier for Quality
• Successfully manage changes following Molex PCN procedure to ensure adequate qualification in place and no violation against customer change management requirements
• Focus on product and process risks to ensure minimization in COPQ in the whole life cycle of products. Lead quantum COPQ reduction for key product families and/or value streams with great urgency
• Focus on continuous supplier quality improvement by strengthening control in systematic supplier development and daily management. Qualify and develop subcontractors to ensure products manufactured outside of Molex Singapore are free of defects
• Coach and enhance the communication of Principle Based Management (PBM) framework and guiding principles within the Quality organization of Molex Singapore
• Develop talents in the organization to be contribution-motivated to maximize their contribution to the long-term success of Quality group in Molex Singapore
• Fulfill Supervisor Responsibilities in PBM framework and actively coach supervisors in the team to act the same. Drive direct and indirect subordinates to hold themselves more accountable by lowering the decision rights
• Manage key transformation initiatives of quality organization, including full deployment and utilization of Opcenter and MOS
• Create the right environment by fostering inclusion, adopting the challenge process and honest communication
• Other duties as assigned by Management

Who You Are (Basic Qualifications)

• Bachelor’s degree in Engineering or Technology (Master’s or MBA preferred).
• Minimum 15 years in quality management with at least 10 years in supervisory roles.
• Experience across multiple quality functions: customer, supplier, manufacturing quality, and QMS.
• Strong leadership skills with the ability to influence and enhance quality culture.
• Proficient in 8D methodology, PFMEA, Control Plans, capability studies, MSA, PPAP, and safe launch.
• Skilled in supplier quality management, audits, and development.
• Excellent communication and teamwork skills.
• Willingness to travel for customer and supplier visits.

What Will Put You Ahead

• Lean Six Sigma Black or Green Belt certification.
• Knowledge of connector and cable manufacturing processes.
• Experience with GD&T, reliability engineering, and industrial standards (IPC, ESD).
• Proven track record in continuous improvement and breakthrough quality initiatives.

At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate’s knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.

Who We Are

As a Koch company, Molex is a leading supplier of connectors and interconnect components, driving  innovation in electronics and supporting industries from automotive to health care and consumer to data communications. The thousands of innovators who work for Molex have made us a global electronics leader. Our experienced people, groundbreaking products and leading-edge technologies help us deliver a wider array of solutions to more markets than ever before.

At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company. 

Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.

Responsibilities

• Establish and maintain PV quality management system, ensuring the full compliance with GVP, relevant regulatory requirements, as well as all applicable health authority requirements mainly in EU and China.
• Manage PV controlled procedures, including policy, SOP, etc.
• Conduct PV quality activities, including audits, change control, deviation and CAPA management, KPIs  (Key Performance Indicators) monitoring, training management, etc.
• Qualifies PV CSO (Contract Service Organization).
• Manage PSMF (Pharmacovigilance System Master File).
• Manage the drafting and updating of Safety Agreements, and ensure the periodic reconciliations with partners.
• Manage any PV Inspection from Health Authorities or PV Audit form Partners
• Handle the other ad hoc tasks as required by Superiors.

Requirement

• At least bachelor degree in clinical medicine, pharmacy, life science, etc.
• 7-9 years or above experiences of PV operation or quality management, and at least 3-5 years experiences of PV quality management.
• Familiar with GVP and applicable regulatory requirements for China, EU, etc.
• Experience in pharmaceutical, biotech, CRO, or related regulated environments is preferred.
• Extensive knowledge of PV quality assurance principles, practices and standards.
• Good understanding, communication and learning skills.
• Fluent in English and Chinese for effective communication with Chinese-speaking stakeholders and review of regulatory documents

Roles and Responsibilities

• Lead the full design and implementation of an integrated ISO 9001, IATF 16949, and ISO 26262 management system, including defining organizational scope, mapping end-to-end processes, developing controlled procedures, and establishing measurable quality and safety objectives

• Serve as the Management Representative for ISO certification audits.

• Develop and maintain core QMS processes: document control, change management, risk management, internal audit and management review.

• Establish supplier quality requirements, quality agreements, and OSAT performance metrics.

• Conduct internal audits and coordinate corrective actions (8D, CAR management).

• Drive continuous improvement initiatives across the organization.

• Oversee customer complaint management, field quality, and product traceability.

• Train employees on QMS requirements, procedures, and compliance expectations.

Requirements

• Minimum a Bachelor’s Degree in Engineering (Electrical/Electronics/Mechanical preferred)

• At least 8 years of working experience in the related semiconductor industry

• Knowledge of ISO/IATF standards, quality tools and OSAT processes.

• Agile in crisis management

HOW TO APPLY:

Interested applicants, kindly click on “APPLY NOW”

We regret only shortlisted candidates will be notified.

Important Note: Trust Recruit Pte Ltd is committed to safeguarding your personal data in accordance with the Personal Data Protection Act (PDPA).

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Trust Recruit Pte Ltd

EA License No: 19C9950

EA Personnel: Pang Seng Leng Diana

EA Personnel Reg No: R1106651

Funding Societies is the largest unified SME digital loans platform in Southeast Asia. It is licensed and registered in Singapore, Indonesia, Thailand, Malaysia, and operating in Vietnam. The FinTech company provides THB35 billion annually in business loans to small and medium-sized enterprises (SMEs).

In Thailand, we operate under a debt-crowdfunding license granted by the Securities and Exchange Commission (SEC) and also provide direct lending services to SMEs. Our mission is to uplift societies in Southeast Asia by creating financial opportunities for everyone. We are committed to solving the SME financing gap in the region while providing convenient and short-term fixed-income investment options to individuals and institutions.

We are in search of a Compliance who will oversee all business and operations relating to Compliance including policies, investments, and procedures for Thailand, and supporting Compliance related activities across other SEA countries. He/She will assist, develop and implement company policies and procedures including enterprise-wide risk management, fit and proper checks, business continuity management and outsourcing framework.

What you will do:

• Subject matter expert on AML/CFT and KYC issues
• Manage information requests and liaison communication with the SEC and other government agencies
• Design, evaluate, maintain internal policies, and coordinate with different department managers to help shape the company's approach on Compliance and related matters
• Regularly assess the efficiency of control systems and recommend improvements.
• Review, evaluate and audit company procedures and reports to identify hidden risks or common issues.
• Lead employee training sessions on compliance issues.
• Perform compliance review on outsourcing vendors.
• Maintain various compliance and regulatory registers

What we are looking for:

• Bachelor’s degree in law, business administration, or relevant field.
• A minimum of 3-5 years’ experience as a compliance officer, or similar position.
• Strong knowledge of industry processes and regulations.
• Outstanding communication and interpersonal abilities.
• An analytical mindset with excellent organizational skills
• Fintech related compliance experience preferred

• Time off - We would love you to take time off to rest and rejuvenate. We offer flexible paid vacations as well as many other observed holidays by country. We also like to have our people take a day off for special days like birthdays and work anniversaries.
• Flexible Working - We believe in giving back the control of work & life to our people. We trust our people and love to provide the space to accommodate each and everyone's working style and personal life.
• Medical Benefits - We offer health insurance coverage for our employees. Our people focus on our mission knowing we have their back for their loved ones too.
• Mental Health and Wellness - We understand that our team productivity is directly linked to our mental and physical health. Hence we have Wellness Wednesdays and we engage partners to provide well-being coaching. And we have our Great FSMK Workout sessions too to keep everyone healthy and fit!
• Learning & Development - We believe learning should never end and we support everyone with self-learning L&D allowances.
• Tech Support - We provide a company laptop for our employees and the best possible support for the right equipment/tools to enable high productivity

Interested to know more about us? Learn about our Stories here.

Associate has the part responsibility for CRI, CRIN & NHA

Associate is responsible for the project planning of Preventive Quality (PQP).

Associate is in charge for the overall PQP-time scheduling within the project.

Interfaces are mainly to PPS/PQA/ENI-associates. He executes and finalizes the PQP-activities.

Therefore, he bears the full responsibility and is responsible for the part release at the supplier.

Associate is part of the SE-Team work and supports PPS in preparation of PE/PRs.

Job Description

• Industry/ Organization Type: Manufacturer – Dairy Products
• Position Title: QA Manager / Senior Quality Manager
• Working Location: Pioneer (Transport provided from Boon Lay)
• Working Hours: 5 days (Mon to Fri: 8:00am – 5.30pm)
• Salary Package: Basic + AWS + Performance Bonus
• Duration: Permanent

Key Responsibilities

• Lead site quality and food safety strategy to ensure full compliance with FSSC/ISO 22000, MUIS Halal, SFA/export, customer, and regulatory requirements.
• Manage and coach QA/QC team and work closely with Production, Warehouse, R&D, and Finance to meet quality, safety, and operational goals.
• Own and continuously improve the Food Safety Management System (FSMS), including SOPs/work instructions, HACCP, hazard/risk assessments, validation, and verification.
• Ensure strong GMP, hygiene, allergen control, food defense, and food fraud implementation across operations.
• Lead internal and external audits (certification, customer, regulatory, Halal); act as main audit contact; ensure audit readiness and on-time closure of nonconformities (CAPA).
• Plan and conduct routine inspections and internal audits for Production areas, storage/warehouse, and external production-related areas (e.g., loading bays); identify gaps/risks and drive corrective actions.
• Oversee laboratory and monitoring programs (raw material, in-process, finished goods, environmental); review results/trends; manage OOS/abnormal results; coordinate with internal/external labs and optimize testing cost.
• Act as Food Safety Team Leader for incidents/deviations; lead investigations, decisions, and escalation; manage recall and mock recall exercises and maintain traceability readiness.
• Drive cost control and continuous improvement by monitoring quality costs (rework, waste, disposal, testing, manpower, packaging) and reducing defects, waste, and non-conformities without compromising compliance.
• Plan and deliver training for QA/QC and Production; build annual training plan; assess effectiveness; maintain training and competency records.
• Ensure strong documentation control, recordkeeping, and data integrity; provide quality KPIs and reporting in management reviews.
• Support trials, process changes, and new product development to ensure safe, compliant implementation.
• Handle other ad-hoc tasks as assigned.

APPLY NOW!!!

• Diploma/Degree in Food Science/Food Technology/Microbiology (or related).
• Certified FSSC 22000 / ISO 22000 internal auditor.
• 5+ years QA/QC or Food Safety experience in food manufacturing with FSSC/ISO systems.
• Strong knowledge of FSSC 22000, ISO 22000, HACCP, GMP, MUIS Halal.
• Hands-on experience in audits, inspections, compliance, incident/recall handling, and training.
• Strong leadership, communication, and problem-solving skills; lab trend analysis/cost control is an advantage.

Kindly apply through ANY of the following methods:

• Submit your application by clicking the APPLY button;
• Email your resume to Job@anradus.com.sg. Please indicate #81796 on the email subject.

Anradus Application Policy: We value each application and ensure every resume is reviewed. Our process is efficient, typically concluding within 3 working days. If you do not receive communication from us within this timeframe, it's likely that your application has not been shortlisted by our client. In such cases, we recommend continuing your job search to maximize your opportunities.

Anradus Pte Ltd | EA License No. 20C0161 | Rachael Lee | EA Reg No.: R2093131

Job Description

• Industry/ Organization Type: Manufacturer – Dairy Products
• Position Title: QA Manager / Senior Quality Manager
• Working Location: Pioneer (Transport provided from Boon Lay)
• Working Hours: 5 days (Mon to Fri: 8:00am – 5.30pm)
• Salary Package: Basic + AWS + Performance Bonus
• Duration: Permanent

Key Responsibilities

• Lead site quality and food safety strategy to ensure full compliance with FSSC/ISO 22000, MUIS Halal, SFA/export, customer, and regulatory requirements.
• Manage and coach QA/QC team and work closely with Production, Warehouse, R&D, and Finance to meet quality, safety, and operational goals.
• Own and continuously improve the Food Safety Management System (FSMS), including SOPs/work instructions, HACCP, hazard/risk assessments, validation, and verification.
• Ensure strong GMP, hygiene, allergen control, food defense, and food fraud implementation across operations.
• Lead internal and external audits (certification, customer, regulatory, Halal); act as main audit contact; ensure audit readiness and on-time closure of nonconformities (CAPA).
• Plan and conduct routine inspections and internal audits for Production areas, storage/warehouse, and external production-related areas (e.g., loading bays); identify gaps/risks and drive corrective actions.
• Oversee laboratory and monitoring programs (raw material, in-process, finished goods, environmental); review results/trends; manage OOS/abnormal results; coordinate with internal/external labs and optimize testing cost.
• Act as Food Safety Team Leader for incidents/deviations; lead investigations, decisions, and escalation; manage recall and mock recall exercises and maintain traceability readiness.
• Drive cost control and continuous improvement by monitoring quality costs (rework, waste, disposal, testing, manpower, packaging) and reducing defects, waste, and non-conformities without compromising compliance.
• Plan and deliver training for QA/QC and Production; build annual training plan; assess effectiveness; maintain training and competency records.
• Ensure strong documentation control, recordkeeping, and data integrity; provide quality KPIs and reporting in management reviews.
• Support trials, process changes, and new product development to ensure safe, compliant implementation.
• Handle other ad-hoc tasks as assigned.

APPLY NOW!!!

• Diploma/Degree in Food Science/Food Technology/Microbiology (or related).
• Certified FSSC 22000 / ISO 22000 internal auditor.
• 5+ years QA/QC or Food Safety experience in food manufacturing with FSSC/ISO systems.
• Strong knowledge of FSSC 22000, ISO 22000, HACCP, GMP, MUIS Halal.
• Hands-on experience in audits, inspections, compliance, incident/recall handling, and training.
• Strong leadership, communication, and problem-solving skills; lab trend analysis/cost control is an advantage.

Kindly apply through ANY of the following methods:

• Submit your application by clicking the APPLY button;
• Email your resume to Job@anradus.com.sg. Please indicate #81796 on the email subject.

Anradus Application Policy: We value each application and ensure every resume is reviewed. Our process is efficient, typically concluding within 3 working days. If you do not receive communication from us within this timeframe, it's likely that your application has not been shortlisted by our client. In such cases, we recommend continuing your job search to maximize your opportunities.

Anradus Pte Ltd | EA License No. 20C0161 | Rachael Lee | EA Reg No.: R2093131

About The Company 

KGI Securities is a leading multi asset brokerage firm with presence across several countries in Asia and a pioneer member of the Securities & Derivatives, Trading and Clearing Member of Singapore Exchange, ICE Futures Singapore, ICE Clear Singapore, APEX and Abaxx.

We hold a Capital Markets Services License, is regulated by the Monetary Authority of Singapore (MAS) and is also an equal opportunity employer.

About The Job

The duties of the Associate/Manager - Compliance officer will include providing regulations guidance and training, consultation of securities and futures trading laws, as well as timely update of relevant laws and regulations. It is also responsible for supervising the periodic self-assessment of legal compliance among all units.

Job Responsibilities

• Provide compliance advisory support and guidance to back and front office regarding compliance with applicable laws, regulations and rules
• Conduct Compliance reviews and testing including trade surveillance, AML and BSC, and escalate any breaches of regulatory requirements or misconduct or company policies
• Develop compliance review programmes, self-assessment questionnaire and any other compliance programmes as may be required by Head of Department, front and back office, parent company, regulators and authorities
• Carry out any advisory, compliance tasks or projects as and when necessary as directed by the Head of Department
• Review and process registration of trading representatives
• Liaise with relevant regulators and Head Office on any major findings and other compliance reporting requirements
• Review and update policies and procedures
• Monitor for regulatory updates and ensure effective implementation of the revised regulatory requirements
• Carry out awareness briefing and staff training on regulatory requirements, company policies and procedures
• Any other ad-hoc responsibilities assigned

Requirements

• Degree holder with minimum 5 years of relevant experience
• Familiarity with the relevant laws, regulations and exchange rules in the securities and/or futures market (SFA, FAA, SGX-ST Rules, Futures Trading Rules, Exchange Rules)
• Meticulous, positive attitude and pro-active
• Strong communication, interpersonal, analytical and organizational skills
• Team player yet able to work independently and interact with people at all levels
• Relevant experience in brokerage firms, financial institutions, public accounting firms are encouraged to apply

Your Job
Support or lead setting goals, policy and direction for Singapore AQP team. Manage and plan for running an effective AQP team to satisfy the smooth running of NPI APQP process and flawless launch of new products. Setup an effective AQP governance and system that is effective and meet customer’s requirement and industrial expectation. To deploy Principles Based Management (PBM) philosophy and thinking framework to AQP team

Our Team
You will lead a dedicated Quality team consisting of Supervisors, Engineers, Technicians, and Inspectors supporting the Datacom and Specialty Solution division. The team works closely with internal stakeholders such as Product Design, Manufacturing, Project Management, Quality, Automation, NPI and HR teams.

What you will do

• Lead and Manage AQP Group: Oversee and allocate resources for the AQP team to support New Product Development (NPD) at Singapore Development Center, ensuring all new product releases meet or exceed customer expectations.
• Implement Quality Policies and Initiatives: Support the Development Director in executing quality programs and initiatives to drive successful product development and introduction.
• Manage New Product Quality Notifications (QNs): Review and control New Product QNs, working to reduce their occurrence by improving workflows and systems.
• Develop and Train AQP Team: Build a technically competent and resilient team by setting high standards, identifying skill gaps, facilitating training, and providing coaching or mentoring.
• Maintain AQP Tools and Assessments: Keep the AQP Technical Competency Matrix and Project Evaluation Matrix up to date; conduct project reviews and provide feedback on completed projects.
• Collaborate Cross-Functionally: Work closely with Product Design, Project Planning, Product Compliance, Model Shop, NPI Assembly, and Reliability Lab to enhance the New Product Development process.
• Standardize Workflow and Knowledge Sharing: Coordinate efforts to standardize AQP workflows and continuously upgrade team knowledge.
• Lead Special Projects: Take on assignments such as line audits, yield improvement programs, new initiatives, and training for other entities as directed by senior Management.
• Perform Other Duties as Assigned by Management.
  

Who You Are (Basic Qualifications)

• Bachelor’s degree in engineering
• Minimum 10 years in quality management with at least 5 years in Quality function and Supervisory role.
• Assertive Leadership style to influence and build consensus to align team on best possible outcome.
• Sense of urgency to drive transformation and organizational improvement.
• Committed to grow and develop the team through coaching and challenge process.
• Strong practical knowledge of quality management and core quality tools.
• Proficient use of statistical tools for data analysis.
• Relevant and proven effective experience in problem solving, respective tools/methodologies.
• Strong interpersonal skills and leadership
• Skills in handling customer and good in system thinking.

What Will Put You Ahead

• 5 years of relevant experience in Advance Quality Planning / Quality management or New Product Launch
• Knowledge of connector and cable manufacturing processes.

At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate’s knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.

Who We Are

As a Koch company, Molex is a leading supplier of connectors and interconnect components, driving innovation in electronics and supporting industries from automotive to health care and consumer to data communications. The thousands of innovators who work for Molex have made us a global electronics leader. Our experienced people, groundbreaking products and leading-edge technologies help us deliver a wider array of solutions to more markets than ever before.

At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company. 

Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.

Job Responsibilities :

· Conduct AML/KYC periodic reviews on high risk and high net worth customers as well as customers who are public figures.

· Provide advice to staff regarding due diligence, Know Your Customer (KYC) standards, internal policies and local regulations

· Review and analysis of transactions surveillance alerts

· Review and analysis of name screening alerts

· To assist and facilitate the training for the staff of Business

· Handle ad hoc assignments

Job Requirements :

· Degree of relevant discipline

· 7 - 8 years’ of relevant experience, preferably in the private banking industry

· Sound knowledge in AML regulatory requirements

· Able to work independently under pressure and accomplish tasks assigned within tight deadline

· Exhibit positive attitude and a good team player

· Effectively bilingual in English and Mandarin as the role requires communication with Mandarin speaking colleagues in Taiwan.

Responsibilities:

• Maintain accurate and up-to-date ISO 9001, ISO 14001, and ISO 13485 documentation, including Quality Manuals, procedures, work instructions, and records, to ensure system compliance and management review readiness.
• Plan, coordinate, and conduct internal and external audits to ensure organizational readiness for third-party certification, management reviews, and customer audits.
• Collaborate with internal stakeholders to support and participate in customer and supplier audits to ensure compliance requirements are met.
• Review audit findings, develop corrective action plans, and drive continuous improvement initiatives.
• Generate and review supplier quality performance reports, work closely with suppliers to resolve non-conformances, and promote continuous improvement.
• Issue, monitor, and follow up on Supplier Corrective Action Requests (SCAR), ensuring effectiveness and timely closure.
• Support qualification and onboarding of new suppliers to maintain a robust pipeline aligned with production requirements.
• Manage calibration schedules and preventive maintenance programs for equipment to ensure operational reliability and compliance.
• Address quality issues arising from production and customer feedback by working closely with production teams to implement corrective actions and resolve customer complaints with proper documentation.
• Ensure timely closure of Corrective and Preventive Actions (CAPA), non-conformance reports, and customer complaints, and publish quality performance reports.
• Lead Material Review Board (MRB) meetings with cross-functional teams to perform root cause analysis, implement corrective actions, and verify effectiveness.
• Supervise and lead QC inspectors to ensure parts inspection compliance with engineering drawings and quality standards.

Qualifications:

• Diploma in Quality Management, Engineering, Manufacturing, or a related field.
• Min 3 years of relevant experience in quality or manufacturing environments, with exposure to audits and documentation.
• Basic understanding of supplier management and quality coordination.
• Familiarity with commonly used quality management standards (e.g. ISO systems).
• Working knowledge of quality tools and process control methods.

We regret only shortlisted candidates will be contacted. All applications will be handled confidentially. By submitting your application, you agree to the collection, use, retention, and disclosure of your personal information to prospective employers.

Wecruit Pte Ltd

EA License No: 20C0270

EA Personnel: Nyon Hock Sen (Aden)

EA Personnel Reg No: R24124070

Summary

The Manager/Senior Manager, Quality Assurance & Regulatory Affairs (QA/RA) will be responsible for establishing, implementing, and maintaining a compliant and robust Quality Management System (QMS) in accordance with ISO 13485, EU MDR2017/745, and FDA 21 CFR Part 820 (QMSR).

This role will lead Quality Assurance (QA), Quality Engineering (QE), and Regulatory Affairs (RA) functions to support the development and manufacturing of Class III implantable medical devices, including pericardial patches and biological heart valves.

The position will play a critical role in ensuring regulatory compliance, product quality, and successful market access (CE mark and FDA approval).

Responsibilities

·       Lead and support the development and execution of regulatory strategies for CE marking and FDA submissions.

·       Lead and facilitate regulatory inspections, including Notified Body audits and FDA Pre-Approval Inspections (PAI).

·       Drive quality engineering initiatives, including process validation, risk management, processo ptimization, and continuous improvement.

·       Oversee key quality systems, including CAPA, internal audits, complaint handling, and supplier quality management.

·       Collaborate cross-functionally with Engineering, Manufacturing, and R&D, and act as the management representative for quality and regulatory compliance.

·       Establish and maintain the Quality Management System documentation, including the Quality Manual, SOPs, document control, and records management.

Requirements

·       Bachelor’s degree or higher in Biomedical Engineering, Life Sciences, Chemical Engineering, or a related discipline.

·       Minimum 10 years of relevant experience in the medical device or pharmaceutical industry, including at least 5 years in a leadership capacity.

·       In-depth knowledge of FDA 21 CFR Part 820, EU MDR2017/745, ISO 13485, and ISO 14971.

·       Familiarity with industry standards such as ISO 14644 (cleanroom manufacturing), ISO 10993, and ISO 5840 would be advantageous.

·       Proven experience in regulatory submissions (CE Mark and FDA) for Class III implantable medical devices is highly preferred.

·       Demonstrated strong leadership and team-building capabilities, with the ability to operate effectively in a start-up or greenfield environment.

·       Excellent communication and stakeholder management skills, with the ability to engage senior management, regulatory authorities, and external partners.

·       Strategic mindset with hands-on execution capability, coupled with a high level of accountability and attention to detail.

Responsibilities: 

• Develop and maintain an operational risk management framework that aligns with the organization's objectives, ensuring it meets all necessary requirements. 

• Implement and embed the operational risk management policy across multiple local entities. 

• Collaborate with first-line management to support and maintain the internal control framework and testing methodologies. 

• Deliver internal control testing campaigns, documenting results in the risk management tool and reporting outcomes through appropriate channels. 

• Oversee the Quarterly Control Evaluation (QCE) process across local entities, including the reporting of management results and remediation plans. 

• Contribute to the implementation of the Operational to Secure Subsidiaries (OSS) framework. 

• Engage in community calls to communicate key updates between the risk management and internal control functions. 

• Build and maintain strong relationships with stakeholders in Risk, Compliance, and Internal Audit to ensure effective oversight of the control framework. 

• Maintain a risk and control tracker to ensure management teams are aware of their commitments to audits and regulators. 

• Participate in risk management forums and governance meetings to provide oversight and support for operational risk management initiatives. 

Requirements: 

• Degree-level qualification or equivalent is essential. 

• A minimum of several years of experience in Audit, Finance, or Risk Management within a regulated environment. 

• Familiarity with the insurance sector, particularly international health, is preferred but not mandatory. 

• Knowledge of technology, security, and data risks and their control frameworks is advantageous. 

• Strong understanding of material risk exposures in financial services and internal control frameworks. 

• Expertise in Technology Risk Frameworks (e.g., COBIT, ISF, ISO27001 series) is a plus. 

• Excellent skills in report writing, organization, and analysis, with the ability to influence stakeholders at all management levels. 

• Competence in navigating a matrix organization effectively. 

• Understanding of the Solvency 2 risk environment is preferred but not required. 

Interested candidates who wish to apply for the advertised position, please click on “Apply”. We regret that only shortlisted candidates will be notified. 

EA License No.: 01C4394 (Persol Singapore PTE LTD) 

By sending us your personal data and curriculum vitae (CV), you are deemed to consent to Persol Singapore Pte Ltd and its affiliates to collect, use and disclose your personal data for the purposes set out in the Privacy Policy available at https://www.persolsingapore.com/policies. You acknowledge that you have read, understood, and agree with the Privacy Policy 

Job Description:

• Work as a team to create and implement comprehensive quality assurance plans that outline the processes and procedures for ensuring quality throughout the product lifecycle, from design to manufacturing to delivery.
• Conduct internal and external audits to assess the effectiveness of quality control procedures and identify areas for improvement.
• When quality issues are identified, work to determine the root cause of the problem, develop corrective actions, and monitor their implementation to ensure they are effective.
• Ensure that company's products and services meet relevant industry standards and regulations, including standards like NADCAP.
• Provide training and awareness programs for employees on quality control procedures and best practices.
• Actively participate in continuous improvement projects to enhance quality and reduce costs.
• Collaborate with suppliers to ensure that their products and services meet the required quality standards.

Requirement:

• Min degree in Engineering
• Min 3 years of experience in certifying staff and lead QA activities

To submit your application, please apply online to apply@rn-care.com or call +(65) 6513 5697 for private and confidential discussion.

Your interest will be treated with the strictest of confidence. We regret that only shortlisted candidates will be notified or contacted.

RN Care Pte. Ltd
EA License No: 17C8900