SR QA Officer (Risk Assessment)

SR QA Officer (Risk Assessment)

Job Title: SR QA Officer (Risk Assessment)
Contract Type: Permanent
Location: UK
Salary: £40000 - £41000 per annum
Reference: HQ00046858
Contact Name: Connor Sealy
Contact Email:
Job Published: September 30, 2016 14:50

Job Description

An exciting global pharmaceutical company is looking for somebody to join their growing medical devices operations. With a good location, international working opportunities and an expanding department, this position involves providing support for product release into the European market in a risk assessment function. 

The responsibilities of the role involve, amongst others:

  • Preparing and reviewing FMEcA risk assessments, relating to QP product release. 
  • Reviewing and updating medical device product risk assessments as per ISO 14971. 
  • Responsible for preparing and reviewing transportation route temperature excursion risk impact assessments as per Annex 16 (EU cGMP). 
  • Preparing and reviewing excipient and facility risk assessments. 

A successful applicant will need to be experienced in the risk assessment of medical devices. A strong, technical understanding of medical devices is preferred, with confident working knowledge of ISO 13485 and 14971 regulations, and quality systems. 

To inquire further into this position, please contact Connor Sealy at Lawrence Harvey, via telephone or email. 

  • 0203 327 3072

Lawrence Harvey is acting as an employment agency in regards to this position.
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