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Quality Assurance Manager – Leeds

Full Time Permanent @Medical Device Client in Medical Devices
  • Leeds, LS1 View on Map
  • Post Date : January 17, 2023
  • Apply Before : March 31, 2023
  • Salary: £45,000.00 - £50,000.00 / Yearly
  • 0 Application(s)
  • View(s) 38
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Job Detail

  • Job ID 550
  • Experience 5 Years
  • Industry Medical Device

Job Description

To ensure that the company’s QMS and quality practices remain compliant with appropriate standards and regulations including ISO13485:2016 and 21 CFR Part 820.

Good, allround knowledge of medical device quality systems with direct experience of EN ISO 13485:2016, 21 CFR Part 820, EU MDR and UK MDR, ideally with experience of transitioning from
EU MDD to MDR.

A minimum of 5 years’ experience in QA or RA in a highly regulated manufacturing environment, with at least 2 years in medical devices or diagnostics.

Extensive experience handling deviations and non conformances, investigations, root cause analysis and corrective/preventive action plans.

Experienced in auditing to EN ISO 13485:2016.

A graduate qualification or equivalent, preferably in scientific or technical discipline

Required skills

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