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Cure Talent are delighted to be working with an exceptional International Medical Device Manufacturer who, due to their continued growth, have a superb opportunity for a QMS Engineer to join the team.
We are looking for an experienced Quality Assurance professional with a strong background in medical device manufacturing. In this role, you will take ownership of assigned areas of the QMS, driving improvements, maintaining compliance with ISO 13485 and ISO 14001, and supporting the QA/RA team and wider business on quality-related matters.
The ideal candidate will have proven experience in Quality Assurance within the medical device industry, a strong understanding of ISO 13485 and MDSAP, expertise in using quality investigational tools, and experience conducting internal and supplier audits. A Lead Auditor certification and knowledge of risk management processes are highly desirable.
Key responsibilities
- Supporting quality-driven, technology-focused projects
- Developing and updating QMS procedures and associated documentation
- Conducting internal and supplier audits
- Managing and implementing CAPAs
- Performing gap analyses for standards and regulations
- Supporting product risk assessments
- Driving continuous improvement projects with a focus on sustainability
- Providing QA support for new product development and design changes
The ideal candidate will have the following skills and experience:
- Proven experience in a Quality Assurance role within the medical device industry
- Knowledge of ISO 13485:2016, ISO 14001, and MDR
- Experience with CAPAs, risk management (ISO 14971), and quality investigational tools
- Lead Auditor trained and certified
- Ability to work independently on key projects and mentor team members
- Strong communication and problem-solving skills, with the ability to influence stakeholders
If you're looking for an exciting opportunity to be part of an established, market leading Medical Device company, get in touch now.
