Senior Quality Systems Specialist

Russell Tobin; Singapore; On-site; SGD 90,000 - 120,000; Full time

Job summary

Russell Tobin is seeking an experienced Quality Assurance professional for Singapore with 5+ years in the medical device sector. The role focuses on ISO 13485-based QMS, GDP/GDPMDS compliance, and regulatory inspections.

You will lead audits, CAPA activities, and stakeholder coordination with regulatory bodies to ensure Singapore regulatory compliance and continuous QMS improvement.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 5+ years' experience in Quality Assurance and/or Quality Systems within the medical device industry.
• Experience implementing or improving ISO 13485-based QMS.
• Strong knowledge of Singapore medical device regulatory requirements.
• Experience obtaining and maintaining GDP/GDPMDS certifications.
• Stakeholder management with certification/accreditation bodies and regulatory authorities.
• Strong experience with ISO 13485 Quality Management Systems.
• Hands-on experience with GDP/GDPMDS certification and compliance activities.
• Strong knowledge of Singapore HSA medical device regulations.
• Experience leading external audits, certification audits, and regulatory inspections.
• Proven experience obtaining and maintaining GDP/GDPMDS certifications.
• Experience managing CAPA, deviations, non-conformance, and complaint investigations.
• Internal and supplier audit management experience.
• Strong stakeholder management with certification bodies and regulatory authorities.

Responsibilities

• Lead implementation, maintenance, and continuous improvement of QMS.
• Ensure compliance with ISO 13485, GDPMDS, and Singapore regulatory requirements.
• Drive GDP/GDPMDS certification readiness and audit support.
• Conduct gap assessments and remediation activities.
• Manage quality documentation, SOPs, and work instructions.
• Lead internal audits and supplier quality programs.
• Support regulatory inspections and compliance initiatives.
• Deliver quality training and drive continuous improvement programs.

Skills

QA/QMS experience

ISO 13485 knowledge

GDP/GDPMDS certification

Singapore HSA regulations

Audits and CAPA

Stakeholder management

Regulatory inspections

Education

Bachelor's degree in Life Sciences

Job description

We are looking for candidates with 5+ years of experience in Quality Assurance and Quality Systems within the medical device industry. Strong knowledge of ISO 13485, Singapore HSA regulations, and hands-on experience with GDP/GDPMDS certification, QMS implementation, and audit management are essential.

Contract Duration

- 12 months

Must-Have Requirements

• Bachelor's degree in Life Sciences or related field
• 5+ years' experience in Quality Assurance and/or Quality Systems within the medical device industry
• Experience implementing or improving ISO 13485-based QMS
• Strong knowledge of Singapore medical device regulatory requirements
• Experience obtaining and maintaining GDP certification
• Stakeholder management with certification/accreditation bodies and regulatory authorities
• Strong experience with ISO 13485 Quality Management Systems
• Hands-on experience with GDP/GDPMDS certification and compliance activities
• Strong knowledge of Singapore HSA medical device regulations
• Experience leading external audits, certification audits, and regulatory inspections
• Proven experience obtaining and maintaining GDP/GDPMDS certifications
• Experience managing CAPA, deviations, non-conformance, and complaint investigations
• Internal and supplier audit management experience
• Strong stakeholder management with certification bodies and regulatory authorities

Responsibilities

• Lead implementation, maintenance, and continuous improvement of QMS
• Ensure compliance with ISO 13485, GDPMDS, and Singapore regulatory requirements
• Drive GDP/GDPMDS certification readiness and audit support
• Conduct gap assessments and remediation activities
• Manage quality documentation, SOPs, and work instructions
• Lead internal audits and supplier quality programs
• Support regulatory inspections and compliance initiatives
• Deliver quality training and drive continuous improvement programs

Education

• Bachelor's Degree in Life Sciences, Biomedical Sciences, Pharmacy, Engineering, Quality Management, or related field