Senior Quality Systems Specialist

Your tasks

Microsoft Office 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.

Requirements

• 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.

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.

How to apply

Please share your details to Shubhra.Dhanoa@artech.com