Medical Device Compliance Expert

3 weeks ago


Cambridgeshire and Peterborough, United Kingdom Real Full time

About Us

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We are a reputable global Medical Device manufacturing company committed to delivering high-quality products and services.

Job Description

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This Senior Quality Manager role is responsible for overseeing the quality operations at the manufacturing site, ensuring regulatory compliance and quality requirements are met. Key responsibilities include:

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  • Implementing and maintaining ISO 13485 compliance.">
  • Representing the company in regulatory matters.">
  • Providing regular reports to senior management on QMS performance.">
  • Raising awareness of regulatory requirements related to QMS within the company.">
  • Ensuring EU MDR compliance and its verification in line with QMS.">
  • Verifying conformity of medical devices before release.">
  • Maintaining the Quality manual.">
  • Managing CAPA activities and conducting internal audits.">
  • Developing and implementing quality policies.">
  • Collaborating with other teams to ensure regulatory compliance.">
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Requirements

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To be considered for this role, candidates should have a strong background in Quality Management, experience in regulated industries, and excellent communication and leadership skills.



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