Editorial summary

The company, a leading manufacturer in the medical devices sector, is seeking a Quality Engineer specialized in R&D and ISO13485 compliance to support new product development and ongoing projects. The role involves providing quality and compliance support throughout the product lifecycle, including design reviews, verification, validation, and usability studies. The position is based in the eastern region and offers a salary of 8,000. The ideal candidate will have experience in medical device quality management and regulatory standards.

This summary is AI-generated and may contain inaccuracies. Please refer to the full job description below.

Job description

[This job id 17918 first appeared in Job-Q.com on 04 Jul 2026]

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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