R&D Quality Engineer (Medical Devices - ISO13485)

Our client is one of the leading players in the medical devices manufacturing sector. Due to business needs, they are now recruiting a Quality Engineer to be part of their Quality team for ongoing transformation projects. They are located in the east. The Quality Engineer's responsible is:

• Act as the Quality representative for new product development and sustaining projects within the medical device portfolio.

• Provide quality and compliance support throughout the product development lifecycle, including design changes, design reviews, verification & validation, usability studies, process validation, and labeling activities.

• Lead risk management activities, including Risk Management Plans, Hazard Analysis, Risk/Benefit Assessments, and Design/Process FMEA.

• Partner with cross-functional teams to identify product risks, investigate potential failure modes, and implement effective risk control measures.

• Ensure compliance with ISO 13485, FDA regulations, customer requirements, and applicable quality standards.

• Develop, review, and maintain quality procedures, SOPs, and documentation to support product development and Quality Management System (QMS) requirements.

• Support internal, supplier, and external audits, including the investigation and closure of non-conformities.

• Drive continuous improvement initiatives to enhance product quality, process effectiveness, and QMS compliance.

• Serve as a Quality Subject Matter Expert (SME) and provide guidance to engineering and project teams on quality and regulatory matters.

Job Requirements:

• Degree in life science related discipline

• Min 5 years experience in quality design within medical devices sector

• Experience in ISO13485

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv. We regret that only shortlisted candidate will be notified. Email Address: [email protected] Recruitpedia Pte. Ltd. EA License No. 19C9682 EA Reg. No. R2198636 (Oh Puey Xin)