Quality Assurance Manager Medical Devices

Posted 26 October by Principle
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QA Manager Medical Devices

An exciting opportunity for an experienced QA professional to join an international growing medical device start-up who are about to begin their commercialization journey across the US and Europe. This is an exciting time for this one to be watched by MedTech company.

As a QA Manager, you will take full ownership of the Quality Assurance function maintaining the current QMS and managing product quality supporting regulatory submissions and annual reporting to the notified bodies and FDA. This will be a hands-on role with close interaction with the CTO and CEO.

The Offer

  • Salary: Up to £60K
  • Permanent full-time position
  • Fully Remote: But should be physically present in the UK or Ireland
  • Opportunity to play a key role in a medical device start-up who are destined for major growth

Your responsibilities:

  • Maintaining the efficiency of the Quality Management System (QMS) and implementing continuous improvement.
  • Working closely with an external consultant on the CE Marking of the new products and FDA Submissions
  • Responsible for FDA inspections, notified body audits, and other audits and inspections

Your profile:

  • Engineering/Science degree qualification with solid experience within a medical device environment in a similar capacity.
  • Qualified as an internal and external auditor
  • Knowledge of FDA Quality System Regulation, ISO 13485, ISO 14971, MDD, MDR.
  • Experience in writing regulatory device submissions like CE certification, IDEs, and 510(k)

Next Steps...

For further details on this QA Manager role apply now with a CV to SomRajendra in Principle or reach out with your LinkedIn profile. All CVs/profiles will be treated in the strictest confidence.

Required skills

  • FDA
  • Medical Devices
  • Quality Assurance
  • Regulatory Affairs
  • Regulatory Submissions

Reference: 44488174

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