Senior Quality Systems Specialist

scalence pte. ltd.; Singapore; On-site; SGD 90,000 - 180,000; Full time

Job summary

scalence pte. ltd. is seeking an experienced Senior Quality Systems Specialist to drive QMS implementation, maintenance and continuous improvement for medical devices in Singapore.

The role focuses on regulatory compliance with Singapore HSA, GDP/GDPMDS certification activities and interaction with certification bodies. The ideal candidate has 5–7 years in QA/Quality Systems within medical devices, ISO 13485 experience, and strong collaboration across functions to guide organizations through

Qualifications

• Experience implementing or improving ISO 13485-based QMS.
• Experience with Singapore HSA regulatory requirements and certification activities.
• Proven track record in GDP/GDPMDS certification projects.

Responsibilities

• Lead QMS implementation, maintenance and continuous improvement within medical device industry.
• Support certification and regulatory compliance activities with Singapore HSA and GDPMDS/GDP.
• Interact with certification bodies, accreditation bodies, and regulatory authorities.
• Coordinate cross-functional teams to ensure quality processes meet regulatory standards.

Skills

Quality management

Regulatory affairs

GDP/GDPMDS

Cross-functional collaboration

Quality improvement

Education

Bachelor's degree in Life Sciences or related field

Minimum 5-7 years QA/Quality Systems

Tools

Microsoft Office

Job description

We are seeking an experienced and highly motivated Senior Quality Systems Specialist to support the implementation, maintenance, and continuous improvement of Quality Management Systems (QMS) within the medical device industry. The ideal candidate will possess solid experience with Singapore HSA regulatory requirements, GDP/GDPMDS certification activities, and medical device quality systems in Singapore and preferably Malaysia.

This role requires a self-directed professional who can independently lead quality system initiatives with minimal supervision, collaborate with cross-functional stakeholders, and successfully guide organisations through certification and regulatory compliance activities.

• Bachelor's degree or higher in Life Sciences or related discipline
• Minimum 5-7 years of experience in Quality Assurance and/or Quality Systems within the medical device industry.
• Experience implementing or improving ISO 13485-based QMS.
• Strong experience working with Singapore medical device regulatory requirements.
• Demonstrated experience supporting or leading GDPMDS/GDP certification projects.
• Proven track record of successfully helping organizations obtain and maintain GDP certification
• Experience interacting with certification bodies, accreditation bodies, and regulatory authorities.
• Microsoft Office