1,405 Quality Management System jobs in Singapore

• 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.

• Participates in corporate quality planning, short-term & Long-term corporate quality initiatives
• Reports to management on quality issues, trends and losses on a regular basis.
• Coordinate the standardization of systems, procedures and practices across all factory sites.
• Prepares & Attend Management Review meetings of the Quality System.
• Plans and participates in internal and external quality audits.
• Plans and supervises Quality System Audits and evaluates any necessary corrective actions.
• Evaluates the Quality Systems of suppliers
• Manages and updating the Company Quality Manual.
• Interfaces with customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented.
• Interacts with customers to identify opportunities to improve quality and establish feedback with manufacturing and development personnel.
• Perform other quality-related activities as directed by management

• With min. 8-10 years of experience in QA within semiconductor Manufacturing site or similar industry.
• Comprehensive understanding of quality tool (8D, SPC, FMEA, MSA, APQP, etc.).
• Must have training in internal and external auditing to ISO 9001
• Certification preferred -IATF16949, VDA6.3, Six Sigma, etc

Our organization seeks a Quality Management System (QMS) Professional to oversee the implementation and maintenance of our Quality Management Systems.

• Develop and execute strategies for ensuring compliance with regulatory requirements and industry standards related to quality management systems.
• Interface with cross-functional teams to harmonize and align quality management systems and processes.
• Ensure the effectiveness of QMS processes such as audits, corrective actions, change control management, documentation, and training.
• Collaborate with global business process teams to deploy and sustain harmonized processes worldwide.
• Plan and conduct internal and external audits, review technical documents, and provide training and support to users.

• Bachelor's degree in a relevant field, such as engineering or sciences.
• At least three years' experience in quality functions in regulated environments.
• Excellent communication, interpersonal skills, and proficiency in Microsoft Office.
• Able to work independently and as part of a team, with strong attention to detail and time management skills.

Quality Management System Manager

Must have experience in Manufacturing industries like CM or Semiconductor.

Core Responsibilities

• Participates in corporate quality planning, short-term & Long-term corporate quality initiatives
• Reports to management on quality issues, trends and losses on a regular basis.
• Coordinate the standardization of systems, procedures and practices across all factory sites.
• Prepares & Attend Management Review meetings of the Quality System.
• Plans and participates in internal and external quality audits.
• Plans and supervises Quality System Audits and evaluates any necessary corrective actions.
• Evaluates the Quality Systems of suppliers
• Manages and updating the Company Quality Manual.
• Interfaces with customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented.
• Interacts with customers to identify opportunities to improve quality and establish feedback with manufacturing and development personnel.
• Perform other quality-related activities as directed by management

Requirements:

• With min. 8-10 years of experience in QA within semiconductor Manufacturing site or similar industry.
• Comprehensive understanding of quality tool (8D, SPC, FMEA, MSA, APQP, etc.).
• Must have training in internal and external auditing to ISO 9001
• Certification preferred –IATF16949, VDA6.3, Six Sigma, etc

Interested applicants, please kindly email your update resume to We regret to inform that only shortlisted candidates will be notified.

**Job Title:** Quality Management System Specialist

We are seeking a highly skilled and experienced Quality Management System Specialist to join our team. In this role, you will be responsible for implementing and maintaining quality management systems that meet industry standards.

Key Responsibilities:

• Implement and maintain quality management systems that meet industry standards
• Conduct internal audits and external vendor QMS audits
• Liaise with regulatory bodies and ensure compliance
• Manage vendor qualification and approved vendor lists
• Investigate incidents and accidents
• Assist in developing and reviewing quality management procedures

Requirements:

• Minimum diploma in aerospace engineering or related field
• At least 3 years of experience in QMS in the aerospace industry
• Certified auditor required

What We Offer:

• A competitive salary package
• Opportunities for career growth and development
• A dynamic and supportive work environment

How to Apply:

Please submit your application online or contact us for a private and confidential discussion. Your interest will be treated with the strictest confidence. Only shortlisted candidates will be notified or contacted.

• Participates in corporate quality planning, short-term & Long-term corporate quality initiatives
• Reports to management on quality issues, trends and losses on a regular basis.
• Coordinate the standardization of systems, procedures and practices across all factory sites.
• Prepares & Attend Management Review meetings of the Quality System.
• Plans and participates in internal and external quality audits.
• Plans and supervises Quality System Audits and evaluates any necessary corrective actions.
• Evaluates the Quality Systems of suppliers
• Manages and updating the Company Quality Manual.
• Interfaces with customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented.
• Interacts with customers to identify opportunities to improve quality and establish feedback with manufacturing and development personnel.
• Perform other quality-related activities as directed by management

• With min. 8-10 years of experience in QA within semiconductor Manufacturing site or similar industry.
• Comprehensive understanding of quality tool (8D, SPC, FMEA, MSA, APQP, etc.).
• Must have training in internal and external auditing to ISO 9001
• Certification preferred -IATF16949, VDA6.3, Six Sigma, etc

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 (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.
Qualifications
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.
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