1,152 Quality Management System jobs in Singapore

Job Description

• Check on the completeness of documentations of work processes.
• Execute inspections on compliance to procedures.
• Generate reports on documentation checks and compliance and update trends.
• Develop and track follow up actions for non-compliant findings.
• Support the management of feedback, enquiries, appeals and disputes.
• Maintain meticulous records of all audit activities, findings, recommendations and follow-up actions.
• Carry out other administrative duties including, but not limited to filing, recording, despatch, and customer service

Requirements

• Diploma or equivalent.
• Preferably possess WSQ Graduate Certificate in Workplace Safety and Health and relevant ISO auditor certifications.
• Strong understanding of Quality Management Systems, i.e., ISO 9001 principles and other relevant quality standards.
• Basic knowledge of IT and Microsoft Office software/ applications.

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EA Personnel Name: Siti Khatijah

EA Personnel No: R

EA License No: 11C3955

• Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485, GDPMDS, and other applicable regulations.
• Ensure compliance with local and international regulatory requirements, including HSA (Health Sciences Authority) regulations for IVD devices in Singapore.
• Manage documentation processes, including SOPs, work instructions, and records, to ensure accuracy and compliance.
• Prepare for and participate in internal and external audits, including regulatory inspections and customer audits.
• Conduct training sessions for employees on quality policies, regulatory updates, and best practices in quality management.
• Assist in risk assessment and mitigation activities related to product quality and regulatory compliance.
• Investigate non-conformances, implement corrective and preventive actions (CAPA), and monitor their effectiveness.
• Support supplier audits and evaluations to ensure adherence to quality standards.
• Identify opportunities for process improvements and work with teams to enhance efficiency and effectiveness.

• Bachelor's degree in Life Sciences, Biotechnology, Biomedical Engineering, or a related field.
• Minimum of 2 years of experience in quality management, regulatory affairs, or related roles within the medical device or IVD industry.
• Familiarity with ISO 13485, GDPMDS, EU IVDR, FDA QSR, and Singapore's HSA regulations.

• Skills:

• Strong understanding of quality management principles and regulatory requirements.

• Excellent organizational and documentation skills.
• Strong analytical and problem-solving skills.
• Effective communication and teamwork abilities.

• Ability to work independently and manage multiple tasks efficiently.

• Certifications (Preferred): ISO 13485 Lead Auditor or other relevant quality certifications.

Job Responsibilities:

1. Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485, GDPMDS, and other applicable regulations.

2. Ensure compliance with local and international regulatory requirements, including HSA (Health Sciences Authority) regulations for IVD devices in Singapore.

3. Manage documentation processes, including SOPs, work instructions, and records, to ensure accuracy and compliance.

4. Prepare for and participate in internal and external audits, including regulatory inspections and customer audits.

5. Conduct training sessions for employees on quality policies, regulatory updates, and best practices in quality management.

6. Assist in risk assessment and mitigation activities related to product quality and regulatory compliance.

7. Investigate non-conformances, implement corrective and preventive actions (CAPA), and monitor their effectiveness.

8. Support supplier audits and evaluations to ensure adherence to quality standards.

9. Identify opportunities for process improvements and work with teams to enhance efficiency and effectiveness.

Job Requirements

1. Bachelor's degree in Life Sciences, Biotechnology, Biomedical Engineering, or a related field.

2. Minimum of 2 years of experience in quality management or related roles within the medical device or IVD industry.

3. Familiarity with ISO 13485, GDPMDS, EU IVDR, FDA QSR, and Singapore's HSA regulations.

4. Skills:

I. Strong understanding of quality management principles and regulatory requirements.

II. Excellent organizational and documentation skills.

III. Strong analytical and problem-solving skills.

IV. Effective communication and teamwork abilities.

VI. Ability to work independently and manage multiple tasks efficiently.

1. Certifications (Preferred): ISO 13485 Lead Auditor or other relevant quality certifications.

Job Responsibilities:

1. Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485, GDPMDS, and other applicable regulations.

2. Ensure compliance with local and international regulatory requirements, including HSA (Health Sciences Authority) regulations for IVD devices in Singapore.

3. Manage documentation processes, including SOPs, work instructions, and records, to ensure accuracy and compliance.

4. Prepare for and participate in internal and external audits, including regulatory inspections and customer audits.

5. Conduct training sessions for employees on quality policies, regulatory updates, and best practices in quality management.

6. Assist in risk assessment and mitigation activities related to product quality and regulatory compliance.

7. Investigate non-conformances, implement corrective and preventive actions (CAPA), and monitor their effectiveness.

8. Support supplier audits and evaluations to ensure adherence to quality standards.

9. Identify opportunities for process improvements and work with teams to enhance efficiency and effectiveness.

Job Requirements

1. Bachelor's degree in Life Sciences, Biotechnology, Biomedical Engineering, or a related field.

2. Minimum of 2 years of experience in quality management or related roles within the medical device or IVD industry.

3. Familiarity with ISO 13485, GDPMDS, EU IVDR, FDA QSR, and Singapore's HSA regulations.

4. Skills:

I. Strong understanding of quality management principles and regulatory requirements.

II. Excellent organizational and documentation skills.

III. Strong analytical and problem-solving skills.

IV. Effective communication and teamwork abilities.

VI. Ability to work independently and manage multiple tasks efficiently.

1. Certifications (Preferred): ISO 13485 Lead Auditor or other relevant quality certifications.

3 weeks ago Be among the first 25 applicants
Key Responsibilities
Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485, GDPMDS, and other applicable regulations.
Ensure compliance with local and international regulatory requirements, including HSA regulations for IVD devices in Singapore.
Manage documentation processes, including SOPs, work instructions, and records, to ensure accuracy and compliance.
Prepare for and participate in internal and external audits, including regulatory inspections and customer audits.
Conduct training sessions for employees on quality policies, regulatory updates, and best practices in quality management.
Assist in risk assessment and mitigation activities related to product quality and regulatory compliance.
Investigate non-conformances, implement corrective and preventive actions (CAPA), and monitor their effectiveness.
Support supplier audits and evaluations to ensure adherence to quality standards.
Identify opportunities for process improvements and work with teams to enhance efficiency and effectiveness.
Requirements
Bachelor's degree in Life Sciences, Biotechnology, Biomedical Engineering, or a related field.
Minimum of 2 years of experience in quality management, regulatory affairs, or related roles within the medical device or IVD industry.
Familiarity with ISO 13485, GDPMDS, EU IVDR, FDA QSR, and Singapore's HSA regulations.
Strong understanding of quality management principles and regulatory requirements.
Excellent organizational and documentation skills.
Strong analytical and problem-solving skills.
Effective communication and teamwork abilities.
Ability to work independently and manage multiple tasks efficiently.
Certifications (Preferred): ISO 13485 Lead Auditor or other relevant quality certifications.
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Job Responsibilities:

1. Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485, GDPMDS, and other applicable regulations.

2. Ensure compliance with local and international regulatory requirements, including HSA (Health Sciences Authority) regulations for IVD devices in Singapore.

3. Manage documentation processes, including SOPs, work instructions, and records, to ensure accuracy and compliance.

4. Prepare for and participate in internal and external audits, including regulatory inspections and customer audits.

5. Conduct training sessions for employees on quality policies, regulatory updates, and best practices in quality management.

6. Assist in risk assessment and mitigation activities related to product quality and regulatory compliance.

7. Investigate non-conformances, implement corrective and preventive actions (CAPA), and monitor their effectiveness.

8. Support supplier audits and evaluations to ensure adherence to quality standards.

9. Identify opportunities for process improvements and work with teams to enhance efficiency and effectiveness.

Job Requirements

1. Bachelor’s degree in Life Sciences, Biotechnology, Biomedical Engineering, or a related field.

2. Minimum of 2 years of experience in quality management or related roles within the medical device or IVD industry.

3. Familiarity with ISO 13485, GDPMDS, EU IVDR, FDA QSR, and Singapore’s HSA regulations.

4. Skills:

I. Strong understanding of quality management principles and regulatory requirements.

II. Excellent organizational and documentation skills.

III. Strong analytical and problem-solving skills.

IV. Effective communication and teamwork abilities.

VI. Ability to work independently and manage multiple tasks efficiently.

5. Certifications (Preferred): ISO 13485 Lead Auditor or other relevant quality certifications.

We are partnering with a emerging US-based medical equipment manufacturer focusing on innovations that reduce preventable harm and improve health outcomes for maternal and newborn health issues. As part of their expansion, they are looking to hire the following position for their Singapore team.

Quality Management System and Regulatory Manager

Position Overview:

This role oversees QMS and regulatory compliance, serving as ISO 13485 Management Representative and EU MDR PRRC. Responsibilities include ensuring compliance with global regulations, managing audits, submissions, complaints, training, and cross-functional support across the product lifecycle.

Key Responsibilities:

Quality Management System (QMS)

• Serve as the QMS Management Representative as required by ISO 13485.
• Maintain and continuously improve the QMS to ensure ongoing compliance with ISO 13485, EU MDR and FDA 21 CFR Part 820.
• Lead internal audits, management reviews, and risk management activities.
• Drive corrective and preventive action (CAPA) systems and support root cause analysis efforts.
• Monitor and report on QMS performance metrics and key quality indicators (KPIs).
• Ensure proper document control and change management processes are implemented.
• Develop, coordinate and conduct QMS training programs, including onboarding and regular refresher sessions, to ensure employee's understanding and compliance with quality procedures and regulatory requirements.

Regulatory Affairs & Compliance

• Serve as the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the EU MDR for full or selected scope of responsibility.
• Interpret and apply global medical device regulations and standards.
• Lead the preparation and submission of regulatory dossiers and product registrations (e.g., CE Mark Technical Documentation, Asia, Middle East, etc.).
• Maintain regulatory intelligence and proactively communicate changes to the organization.
• Collaborate with marketing and commercial teams to ensure labelling, instructions for use (IFU), and advertisements meet internal regulatory and quality requirements.
• Review and approve global marketing and promotional materials to ensure consistency with approved product claims and compliance with regional regulatory requirements (e.g., EU MDR, FDA advertising and promotional guidelines and other global standards).

Complaint Handling & Vigilance Reporting

• Oversee complaint evaluation and determine whether complaints meet criteria for reportable adverse events/incidents (e.g., EU vigilance).
• Ensure timely reporting to regulatory authorities and maintain appropriate documentation and tracking.

Audit & Inspection Readiness

• Lead the preparation and coordination for external audits by regulatory authorities (e.g. Notified Body audits, regulator inspections).
• Serve as the primary contact during audits and ensure timely resolution of findings and implementation of corrective actions.
• Maintain audit readiness at all times through ongoing training, internal audits, and QMS review.
• Participate in supplier audit, as needed

Education & Experience Requirements:

• Bachelor's degree in science, engineering, or regulatory-related discipline
• Minimum 8–10 years of experience in quality and regulatory roles in the medical device industry.
• Strong knowledge and hands-on experience in implementing and enforcing compliance with ISO 13485, EU MDR and 21 CFR Part 820 across all stages of the product lifecycle. Familiar with ISO 14971.
• Proven ability to manage regulatory compliance activities and QMS in dynamic environment.
• Start-up or scale-up experience within a legal manufacturer setting is highly advantageous, especially in establishing or maturing QMS and regulatory frameworks.
• Demonstrated experience preparing and submitting global regulatory dossiers and managing interactions with regulatory authorities.
• Prior experience in Management Representative and/or PRRC role is highly desirable.

Skills Requirements:

• In-depth knowledge of international regulatory requirements and QMS standards.
• Strong analytical and decision-making skills, particularly for complaint evaluation and regulatory reporting.
• Excellent written and verbal communication skills.
• Self-motivated and proactive leader with a demonstrated ability to work independently and drive cross-functional collaboration across diverse teams.
• Ability to work effectively across different time zones and accommodate night calls when required to support global teams, partners, or regulatory engagements.
• High attention to detail, integrity, and ethical conduct.

EA Personnel Registration No: R

EA License No: 12C6254

Job Scope

• Develop, implement and maintain quality management systems and processes to meet industry standards and customer requirements
• Conduct regular audits and inspections to identify areas for improvement in manufacturing processes
• Analyse quality data and provide recommendations to enhance product quality and efficiency
• Collaborate with cross-functional teams to resolve quality issues and implement corrective actions
• Ensure compliance with all relevant regulations, guidelines and internal policies
• Provide training and guidance to production staff on quality control best practices
• Stay up-to-date with industry trends and advancements in quality management

Requirements

• Bachelor's degree in Mechanical/Aeronautical Engineering or a related field
• 5+ years of experience in a quality assurance or quality control role, preferably in the precision engineering industry
• Strong understanding of Original Equipment Manufacturer from Precisions Manufacturing and special processes like heat treatment, coating.
• Good to have European Aviation Safety Agency regulation exposure.
• Excellent problem-solving, analytical and decision-making skills
• Effective communication and collaboration abilities to work with cross-functional team

EA License No: 13C6305

Reg. No.: R /JULIE RODRIGUES LUBRIN

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Fab10 QEM Quality Management System (QMS) Engineer
Our vision is to transform how the world uses information to enrich life for all.
Join an inclusive team passionate about one thing: using their expertise in the relentless pursuit of innovation for customers and partners. The solutions we build help make everything from virtual reality experiences to breakthroughs in neural networks possible. We do it all while committing to integrity, sustainability, and giving back to our communities.
About Micron
Micron is a global leader in memory and storage solutions, enabling transformative technology that enriches life for all. With over 40 years of innovation, Micron plays a pivotal role in the data-driven economy, where memory and storage are strategic differentiators. We are committed to sustainability, employee well-being, and community support, and we foster a culture of inclusion, collaboration, and continuous improvement.
Job Summary
As a Quality Management System (QMS) Engineer in our Singapore site (F10), you’ll help ensure our processes meet high standards and run smoothly. You’ll work on improving how we manage quality and support various programmes, including:
QMS Planning – achieve ISO 9001 and IATF 16949 International Quality Standards Certification
FMEA (Failure Mode and Effect Analysis) – assessment risk and deploy risk mitigation
MSA (Measurement System Analysis) and Calibration Management – ensure tools give accurate results
Document Control – ensure document integrity
ESD (Electrostatic Discharge) – protect product quality
You’ll also work with global teams to apply quality standards and continuously improve how we operate.
Main Responsibilities
Lead and ensure quality program performance meeting the planned schedule, scope and result.
Manage program changes that includes scope, plan, business rules, policies and procedures.
Work with the program teams to identify project risks and evaluate solutions.
Serve as Local Subject Matter Expert (SME) for assigned quality program.
Represent Fab10 on the quality programs in collaboration with Frontend Operations network and Global Quality.
Manage audit/ customer visit preparation.
Job Requirements, Qualifications
Must have Bachelor’s or advanced degree in Engineering or Science
Must have Python, R, SQL, Tableau, RPA, Power Automate, Power Apps skills
Experience with IATF16949 standard and AIAG Quality Tools is a plus.
Strong analytical, logical, and critical thinking skills
Effective communicator, able to collaborate across all levels
Growth mindset with a passion for continuous learning
Internship or experience in the semiconductor industry is a plus
Demonstrated leadership and a track record of impact are highly desirable
Interest in and knowledge of the semiconductor industry and Micron is preferred
Embody Micron’s core values: Respect, develop, and empower others; Innovation; Tenacity; Collaboration; Customer Focus
What to Expect
Micron is proud to be an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other protected factor.
EEO Statement
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
Micron does not charge candidates any recruitment fees or unlawfully collect any other payment from candidates as consideration for their employment with Micron.
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