Job Details: Senior Design Quality Engineer
Full details of the job.
Job Requisition Name
Job Requisition Name Senior Design Quality Engineer
Job Requisition No
Job Requisition No VN8296
Work Location Name
Work Location Name UK - Bidford
Worker Basis
Worker Basis Full Time
Worker Type
Worker Type Employee
Applications Close Date
Purpose
As a Global Sr. Design Quality Assurance, you will lead design quality across multiple sites, ensuring that new products and ongoing projects are safe, effective, and fully compliant with global regulations (FDA, ISO 13485, MDR). You will partner with R&D, Regulatory, Supply Chain, and Manufacturing to drive quality from concept through commercialization, while supporting key aspects of the QMS, including post-market surveillance and supplier quality.
Key Responsibilities
* Lead design quality assurance for new product development and sustaining projects across multiple sites.
* Ensure compliance with FDA, ISO 13485, MDR, and other global regulations from concept to commercialization.
* Drive risk management activities, including FMEA, risk mitigation, and verification of effectiveness.
* Oversee design transfer, validation, and release of engineering documentation; support design reviews and DHF audits.
* Provide quality input to design specifications, verification/validation, and usability testing.
* Support regulatory submissions and defend design controls during internal and external audits.
* Collaborate cross-functionally to implement process improvements and strengthen the global Quality culture.
Qualification
* 5+ years of medical device engineering experience
* BS in Mechanical, Electrical, or Biomedical Engineering
* In-depth knowledge of FDA, ISO, MDD/MDR, and medical device quality requirements for product development, design controls, and risk management
* Strong understanding of US and international regulations, including 21CFR820, 803, 50, 11, Medical Device Directive/Regulation, EN ISO 13485, EN ISO 14971, IEC 60601, and EN 62366
* Valid visa or right to work in the UK and EU
Company
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