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 Quality Engineer to join the team.
As the new Quality Engineer, 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.
To be successful as the new Quality Engineer, you will have proven experience in Quality Assurance in highly regulated manufacturing, a strong understanding of ISO standards, expertise in using quality investigational tools, and experience conducting internal and supplier audits.
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 a highly regulated manufacturing environment
Knowledge of ISO standards i.e. 9001, 13485, 9100, 16949
Experience with CAPAs, risk management and quality investigational tools
Certified Internal Auditor
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.
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