R&D Quality Engineer (Medical Devices - ISO13485)
1 week ago
Our client is one of the leading players in the medical devices manufacturing sector. Due to business needs, they are now recruiting a Quality Enginee.....
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.
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