Total 1,176 quality control engineer job vacancies in Quality Assurance / Control category

Job Description

As a Quality and Compliance Specialist, you will play a pivotal role in ensuring that all products and operations within Project WATT meet regulatory requirements and quality standards. This role focuses on managing product certification, conducting regulatory audits, and ensuring that operational processes align with local and international laws. Collaborating with technical and operational teams, you will safeguard compliance while driving continuous improvement in quality management.

Responsibilities

• Product Quality Compliance:

1. Ensure that all products (hardware and software) comply with relevant regulations and industry standards, such as TR25 for EV charging systems in Singapore.
2. Maintain and update product certifications and manage regulatory audits and inspections.
3. Review testing results and performance reports to verify adherence to quality standards.

• Operational Compliance:

1. Oversee business operations to ensure alignment with legal and regulatory requirements, such as data privacy and environmental standards.
2. Develop, update, and optimize internal compliance policies and procedures to reflect current regulations.
3. Prepare and submit compliance reports, maintaining effective communication with regulatory authorities.

• Team Collaboration:

1. Work closely with technical teams, including Firmware Engineers and Integration Engineers, to validate the compliance of products and systems.
2. Provide compliance guidance and training to other teams to promote a culture of regulatory awareness.

• Risk Identification and Management:

1. Identify potential compliance risks and recommend actionable improvements to mitigate them.
2. Lead quality and compliance enhancement projects, ensuring continuous improvement in these areas.

Requirements

• A bachelor’s degree in Engineering, Quality Management, Law, or a related field, with at least 3 years of experience in product quality or compliance management. Equivalent professional experience will also be considered.
• Strong understanding of regulatory requirements for EV charging systems or IoT products, including certifications such as TR25.
• Experience managing audits and certification processes with regulatory bodies.
• Proven ability to collaborate effectively with cross-functional teams to ensure adherence to compliance and quality standards.
• Strong analytical and problem-solving skills with meticulous attention to detail in documentation and reporting.
• Knowledge of operational compliance standards, such as data privacy laws or environmental regulations, is a plus.

Reporting to:

Project Manager

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

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

QC Engineer

Salary: $3,000 – $4,000

Working Hours: 8am - 530pm (Mon to Fri)

Location: Tuas

Benefit: AWS, Bonus, Annual Leave, Transport Allowance

Key Responsibilities

Quality Documentation & Compliance

• Maintain and update quality documents (SOPs, work instructions, control plans, FMEA)
• Control and manage drawings and specifications
• Support internal and external audits (customer/certification)
• Track corrective actions and ensure timely closure
• Liaise with cross-functional teams (Production, Engineering, Planning, R&D)

Quality Control Operations

• Supervise QC inspectors on the production floor
• Perform inspections on incoming, in-process, and finished goods
• Review inspection reports and maintain proper records
• Monitor product yield and quality performance
• Manage non-conforming materials and corrective actions
• Analyze data (SPC, Cp, Cpk) to ensure process stability
• Investigate root causes of quality issues and implement solutions
• Support new product and process introduction
• Train QC staff and ensure adherence to procedures

Requirements

• Diploma or Degree in Industrial Engineering, Quality Management, or related field
• 3–5 years of QC/QA experience
• Knowledge of ISO 9001 / ISO 13485 / IATF 16949 preferred

Company Name: Talent Recruitment Pte Ltd

EA License No: 24C2338

EA Personnel Name: Loke Sai Lye (Loke)

EA Personnel No: R24123366

Email: loke.dexter@talentrecruitmentsg.com

Contact Number: 8168 8648

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

Job Summary:

• Responsible for new project measurement planning, tooling and inspection fixture planning, measurement programming, MSA, etc.

Job Duty and Responsibility:

• Develop a measurement plan based on the drawing requirements: correctly select appropriate measuring instruments such as three-coordinate measuring instruments, articulated arms, projectors, calipers, micrometers, height gauges, etc.; determine whether it is necessary to configure inspection fixtures or auxiliary measuring tools, and determine the measurement personnel and cycle.
• Benchmark the measurement plan or measurement results with mold manufacturers and customers.
• Prepare three-dimensional coordinate measurement programming according to drawing requirements and guide technicians/inspectors to correctly perform measurement procedures.
• Develop measurement plans, submit measurement reports to internal and external customers in a timely manner, and explain measurement results to customers when necessary.
• Responsible for the organization and archiving of measurement reports.
• Responsible for writing operating instructions for measuring instruments and auxiliary measuring tools.
• Responsible for training and guiding newly hired measurement technicians/inspectors.
• Participate in the development process of gauges and tooling, and provide effective suggestions on the design and daily maintenance of gauges and measurement auxiliary tooling.
• Regularly organize inspection, daily maintenance and servicing of measuring instruments.
• Participate in the acceptance and annual review of measuring and testing tools.
• Complete other tasks assigned by the leader.

Entry Requirements:

• College degree or above, major in mechanics or polymer materials
• Proficient in GD&T knowledge.
• Proficient in using 3D software such as Pro-E, Solidworks, and Catia; NX
• Be familiar with MSA and master measurement management knowledge.
• Have team leadership ability, strong logical thinking ability and communication and coordination ability.

Working Experience:

• 3 years or more of relevant work experience.
• Priority is given to candidates with production quality management experience in the automotive industry, quality management experience in automotive first-tier suppliers, and experience in automotive fasteners.

Language Skills:

• Be able to write and communicate in English well, able to communicate in Mandarin is an added advantage.

Other Requirements:

• Must be able to travel overseas for meeting / training when required

• Ensure the consistent delivery of high-quality Printed Wiring Boards that meet customer specifications and industry standards by managing quality assurance processes and serving as the primary liaison for customer service accounts.
• Responsible for driving continuous improvement, resolving quality-related customer issues, and upholding compliance with regulatory and internal quality systems to enhance customer satisfaction and product reliability.

Customer Quality Liaison

• Act as the primary contact for customer quality-related inquiries and complaints
• Coordinate resolution of customer issues through root cause analysis and corrective actions

Quality Control Oversight

• Monitor inspection and testing procedures are followed
• Monitor product conformance to IPC and customer-specific standards

Documentation & Compliance

• Maintain quality records in accordance with ISO 9001 and internal QMS protocols
• Prepare and submit quality reports to customers and internal stakeholders

Process Improvement

• Identify recurring quality issues and lead initiatives to improve manufacturing pro
• Support implementation of Problem-Solving methodologies

Audit & Review

• Participate in internal and external audits
• Ensure readiness for customers and regulatory inspection

Training & Support

• Provide guidance to production teams on quality standards and procedures
• Assist in onboarding new staff with QA related training
• Support new product introduction (NPI) with quality input and validation

Requirements:

• Degree in any Engineering discipline (Quality Engineering preferred) in a manufacturing environment
• Min 2 years of experience in Quality Assurance activities/operational
• Good communication, report writing and presentation skills
• Good analytical skills with ability to work effectively
• Independent, decisive and good at problem solving
• Able to adapt in a fast-paced environment
• Preferred with knowledge of PWB manufacturing processes
• Proficiency in Microsoft Office

Electronics MFG Industry

Loyang Area

Interested candidates, please forward a detailed resume and via email to hr@tempserv.com.sg

Tempserv Pte Ltd

License No: 06C3745

Attention: Audris Teo / EA Personnel No: R1102063

The Quality Engineer supports, evaluate and performs activities associated with processes that make up the Quality Management System (QMS). This includes but is not limited to: nonconforming product management and assessment, customer complaints investigation, process control and monitoring, process/equipment change control assessment, Products Transfer, Supporting process validation, and risk management.

How You’ll Make an Impact:

• Facilitate and manage customer complaints that escalate to Manufacturing for investigation
• Work closely with Engineering, Quality Control, SQE for complaints investigation
• Track and monitor complaint investigation until closure
• Support and review Process validation activities and risk management, pFMEA
• Identifies and analyzes actual and potential causes of risk, consequences and control measures and may approve basic to moderately complex investigations, corrective actions.
• Analyzes nonconformances, complaints and trend information to identify and recommend corrective actions and basic application of statistical tools and methods.
• Conducts more in analysis, research as assigned.
• Supports product improvement projects and process changes to ensure validation requirements are met.
• May be assigned basic/simple projects or assignments

What You Bring:

While this list of qualifications may help an employee to succeed in this position, capable candidates may have a wide range of backgrounds or skills. If you have experience that aligns with the responsibilities of this role, we encourage you to apply.

• Bachelor’s degree or equivalent in a related technical discipline
• Quality Engineering, Six Sigma Green or Black Belt Certification desirable
• At least 2 years’ experience or equivalent combination of education and experience.
• Basic knowledge of and application of principles and theories of quality engineering.
• Advanced understanding of GMP/ISO regulations and validation regulations is preferred.
• Working knowledge of the device/drug/biotech manufacturing process.
• Skilled in statistical methods, statistical process control and sampling plans.
• Basic understanding of risk management regulations, principles and application.
• Strong communication, technical proficiency, and computer literacy.
• Excellent coordination abilities, tactfulness, and capacity for effective teamwork.
• Preference given to candidates with strong manual dexterity

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.

Benefits: Bio-Rad's biggest asset is our people, and this is the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle. We’re proud to offer comprehensive medical plans and insurance, flexible benefits, wellness programs, extensive learning and development opportunities and more.

EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply.

Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

Company’s Profile

Julian Grey’s client is a well-established chemical engineering MNC focused on offering sustainable and differentiated products in the chemical industry.

Responsibilities

• Manage quality activities across in coming materials to finished goods, ensuring compliance with customer and regulatory standards
• Analyse quality data using statistical tools(e.g., SPC) to identify trends and drive continuous improvement initiatives
• Maintain and control quality documentation inline with ISO standards and internal quality management systems
• Work closely with cross-functional teams to resolve quality issues and support root cause investigations with corrective actions
• Support customer requirements by preparing quality-related reports, certificates, and documentation (e.g., COA)
• Handle customer feedback and complaints, ensuring proper investigation, documentation, and timely closure
• Participate in internal and external audits, ensuring audit readiness and compliance with ISO9001, ISO14001, and ISO45001standards
• Support supplier quality evaluation, incoming inspections, and sample analysis activities
• Drive risk assessments (e.g., FMEA), training, and continuous improvement initiatives across operations

Requirements

• Diploma in Chemical Engineering, Chemistry, or relevant Science discipline
• Minimum 2-5 years of relevant experience in a manufacturing or chemical environment
• Familiarity with quality management systems and ISO standards (ISO9001, ISO14001, ISO45001)
• Knowledge of statistical analysis tools and quality methodologies (e.g., SPC, root cause analysis)
• Proficient in Microsoft Office applications
• Comfortable working in a cleanroom or production environment

Follow us for more updates, interview tips!
https://www.instagram.com/juliangreygroup/
https://www.linkedin.com/company/juliangreygroup/
https://www.facebook.com/juliangreygroup/
Our telegram channel for job opportunities - https://t.me/jobopportunitiessg

Interested Applicants
Please WA Victoria @ 8887 7742
Shortlisted candidates will be notified

Victoria Siew
Reg No. R25158665
Julian Grey Corporate Advisory Pte. Ltd.
EA License No: 19C9568 

Roles & Responsibilities :

Description:

? Role Overview
The Instrument Cluster & Infotainment Engineer will be responsible for testing, validating, and integrating instrument cluster (IC) and infotainment systems for commercial vehicles. The engineer will work closely with global teams to ensure specification compliance, feature robustness, diagnostics, communication network stability, and system integration.
This role requires strong hands on experience with CANoe, CAPL scripting, ETM (Engineering Test Mode), ECU Test, along with a deep understanding of CAN, LIN, diagnostics and HMI/UX behaviors.
________________________________________
? Key Responsibilities
1. Instrument Cluster (IC) & Infotainment Feature Validation
• Perform system-level and component-level validation of cluster displays, telltales, warnings, animations, HMI, infotainment UI, audio/video, connectivity, navigation, Bluetooth, and telematics.
• Validate functional behavior against Daimler global requirements, DOORS specifications, and model-based requirements.
2. CANoe & CAPL Test Development
• Develop test scripts, simulations, and automated test sequences using CANoe & CAPL for:
o Signal-based testing (CAN/LIN/Ethernet)
o Diagnostic services (UDS/KWP)
o Fault injection
o Network load testing
• Build and maintain CANoe panels, system test harnesses, and simulation nodes.
3. ETM – Test Management tool
• Knowledge on usage of ETM tool to write test cases, requirement traceability and dashboard creation.
4. ECU-Test Automation
• Develop automated regression test suites using ECU TEST, integrate with CANoe, and execute automated test cycles.
• Analyze test results, logs, and create dashboards for defect tracking.
5. Communication & Diagnostics Testing
• Validate end-to-end communication over CAN, LIN, Automotive Ethernet.
• Perform UDS diagnostic verification including:
o DIDs
o Routines
o Sessions
o Fault memory behavior
• Conduct network robustness tests (latency, jitter, busload).
6. Integration & HIL Testing
• Perform integration tests on HiL benches for feature alignment with other ECUs such as BCM, CCU, ADAS modules, powertrain ECUs.
• Debug electrical and communication issues using oscilloscopes, multimeters, and log analyzers.
7. Defect Analysis & Reporting
• Log defects in JIRA or Daimler-specific defect management systems.
• Work with German system owners, suppliers, and cross-functional teams to resolve issues.
• Provide detailed trace logs, reproduction paths, and root-cause indicators.
8. Documentation & Compliance
• Create test plans, test procedures, traceability matrices, and validation reports.
• Ensure compliance with Daimler processes, cybersecurity guidelines, and safety procedures (ISO 26262 awareness).
________________________________________
? Required Skills & Tools
Technical Skills
• Strong knowledge of Instrument Cluster & Infotainment domain
• Automotive communication protocols: CAN, LIN, SOME/IP, Ethernet
• Diagnostics: UDS, OBD, diagnostic testers
• Hands on with:
o CANoe / CANalyzer
o CAPL scripting
o ECU TEST
o ETM
o Vector toolchain knowledge (vTESTstudio optional)
• Ability to interpret DBC, LDF, ARXML, FIBEX files.
• Understanding of E/E architectures, HMI flows, telltale logic, warning prioritization.
Tools
• CANoe, CAPL
• ETM
• ECU TEST
• DOORS / DOORS NG
• JIRA / Polarion
• Oscilloscope, multimeter, bus analyzers
Soft Skills
• Strong debugging & analytical abilities
• Clear communication with global teams (Germany/Japan/US)
• Ability to lead test topics and work independently
• Good documentation discipline
________________________________________
? Preferred Qualifications
• Bachelor’s degree in Electronics, Computer Science, Automotive Engineering, Mechatronics
• Experience in commercial vehicle electronics preferred
• ISTQB certification is a plus
• Exposure to Functional Safety (ISO 26262) and Cybersecurity (ISO 21434)

Pay: Up to $6,000
Location: Kranji (walking distance from MRT)

Duration: 4 months
Work hours: Monday – Friday, 8am - 4:30pm

Job Scope

• Ensure quality oversight at the manufacturing site and in projects, participate in test script execution.

• Participate in the implementation and adherence to various quality systems and GMP requirements at the manufacturing suite

• Participate in meetings with manufacturing for information learning/sharing and alignment of best practices

• Support the manufacturing team with development and writing of standard operating procedures and master batch records in compliance with global procedures and regulatory requirements.

• Review of manufacturing batch records and revision of MBR/MFR/SOP.

• Participate in process improvements/studies with Technical Services and the manufacturing team and draft test scripts

Requirements:

• Minimum few years of experience in pharmaceutical

• Prior experience in SAP

If interested, please email me at pharmascience@recruitexpress.com.sg or telegram @alexgohhl

Alex Goh Hock Leong

(CEI.No: R1763413 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599).

This is a chance to experience a wide range of testing from black box to white box testing on power supply firmware and its accessories. The candidate will work on the digital controls and parameters of the power supplies and systems. The candidate will also have opportunities to collect data and analyse the performance of a running power supply. There will also be an opportunity to develop code stubs for unit testing, GUI for control and data gathering and test equipment automation.

• Create Test Plans from firmware software requirements and test specifications
• Deliver comprehensive and standardized test reports
• Design and build automation drivers, mock tests and automated test setups
• Recommend and design test equipment and test harnesses to cover full product specifications
• Execute unit tests, feature tests, regression tests, and system tests
• Provide proper documentations on all activities related to tests such as System Diagram, Operator’s Manual, Test Flow, and other related items
• Update Azure DevOps accordingly for use in risk management, planning and decision making
• Support production transfers and trainings in US and Asia

• Understand the product roadmap and ensure that testing is conducted as per the QA process.
• Work closely with the test lead to devise test strategies for the applications/projects assigned. Ensure that the test strategy is implemented as per plan.
• Adhere to the QA process, frameworks, principles, and guidelines always
• Have good knowledge and hands on experience of agile testing methodology.
• Ensure that to Sprint/Project timelines are met and any deviations are resolved with the scrum master or reported to the test lead for resolution.
• Ensure that all deliverables including but not limited to feature files/test cases, test results, automated test scripts, automated regression test results etc., are submitted timely and reviewed by the test lead.
• Ensure that all domain, application, functional and technical issues are duly to the test lead for necessary advice, resolution, and support.
• Regularly attend all scrum ceremonies - daily stand up, sprint planning, retrospectives for assigned application/project.
• Ensure that realistic estimates are provided during Sprint Planning.
• Ensure that all test artifacts are uploaded to Zephyr/Test Management Tool and Teams in adherence to the QA guidelines.
• Share EOD status and sign off requests in the standard formats for test lead approval.
• Ensure that all QA KPIs are met, and regular evaluation is conducted with the test lead to ensure that the squad is on track.
• Constantly ideate and come up with innovative solutions to improve the effectiveness & efficiency of QA capabilities.
• Work closely with the test lead to implement new solutions and recommend improvements to the existing processes and frameworks based on regular feedback gathered from the team and from own experience.

SCOPE:

Based on the strategy of the U.S. headquarters, you will ensure that products manufactured and sold in Japan comply with the QMS Ordinance. Specifically, you will bear direct responsibility for maintaining the quality management system in Japan, under Sirtex Global Quality Management System and, in cooperation with overseas manufacturing sites, ensure that the quality management systems at those sites meet the requirements of the QMS Ordinance.

米国本社のストラテジーを踏まえて、日本において製造販売する製品がQMS省令に適合していることを確実にして頂きます。具体的には、グローバル品質マネジメントシステムの下で、日本における品質マネジメントシステムの維持管理に直接的な責任を持って頂くと共に、海外製造所と協力して、海外製造所における品質マネジメントシステムがQMS省令の要求事項を満たしていることを確実にして頂きます。

Candidates must reside in Japan

PRIMARY RESPONSIBILITIES:

• Establishment, Operation, and Maintenance of Quality Management Systems in Japan
  • Management Review
  • Internal Audit
  • Document and Record Control
  • Training and Education
  • Supplier Management (including management of agreements under Article 72 of the QMS Ordinance)
  • Risk Management
  • Complaint Handling
  • Nonconforming Product Control
  • CAPA
  • FCA
  • External Audit Support
  • Market Shipment Approval

• 日本における品質マネジメントシステム体制の構築・運用・維持

  • マネジメントレビュー

  • インターナルオーディット

  • 文書・記録の管理

  • 教育訓練

  • サプライヤー管理（QMS省令第72条における取り決め管理含む）

  • リスクマネジメント

  • 苦情処理

  • 不適合品管理

  • CAPA

  • FCA

  • 外部監査対応

  • 市場への出荷判定

• Ensuring Overseas Manufacturing Sites' QMS Compliance with QMS Ordinance

  • Training

  • Assessment

  • Improvement

  • Monitoring

• 海外製造所における品質マネジメントシステムのQMS省令への適合

  • トレーニング

  • アセスメント

  • 改善

  • モニタリング

• Regulatory Labeling Management

• 法定表示管理

• Regulatory Registration License Management (e.g. MAH License, Overseas Mfg. Site License, Domestic Selling License, etc)

• 業態管理（海外及び国内）

• Other Quality Assurance Activities (Including Government/Industry Relations)

• その他品質保証に関する業務（行政／業界対応含む）