Senior Quality Systems Lead (Remote) — ISO13485 & GDP

Artech Infosystems Private Limited; Singapore; Remote; SGD 90,000 - 150,000; Full time

Job summary

Artech Infosystems Private Limited is seeking a Senior Quality Systems Specialist to drive QMS implementation and continuous improvement for medical devices in Singapore. You will lead GDP/GDPMDS certification efforts and ensure compliance with Singapore HSA regulations across regional operations.

The role requires strong knowledge of Singapore medical device regulations, ISO 13485, and hands-on experience leading quality initiatives.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 5–7 years QA/QMS in the medical device sector.
• Hands-on ISO 13485 QMS implementation and improvement.

Responsibilities

• Implement, maintain and improve ISO 13485-based QMS.
• Lead GDP/GDPMDS certification and compliance activities.
• Ensure Singapore HSA regulatory compliance for medical devices.
• Coordinate with certification bodies and regulatory authorities.
• Prepare and maintain quality documentation and audit records.
• Collaborate with cross-functional teams for certification and commercialization.
• Support Southeast Asia quality system activities, including Malaysia.

Skills

QA/QMS experience

ISO 13485 knowledge

GDP/GDPMDS certification experience

HSA regulatory knowledge

Regulatory project leadership

Education

Bachelor's degree in Life Sciences or related

Job description

Artech Infosystems Private Limited is seeking a Senior Quality Systems Specialist to drive QMS implementation and continuous improvement for medical devices in Singapore. You will lead GDP/GDPMDS certification efforts and ensure compliance with Singapore HSA regulations across regional operations.

The role requires strong knowledge of Singapore medical device regulations, ISO 13485, and hands-on experience leading quality initiatives.