Quality Engineer (Medical Devices - ISO13485)

About the role

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: jobs@recruitpedia.sg Recruitpedia Pte. Ltd. EA License No. 19C9682 EA Reg. No. R2198636 (Oh Puey Xin)

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