Search our vacancies within the Life Science, MedTech and Healthcare sectors below.
Senior Quality Engineer – Site Based – Yorkshire - Medical
About the Company:
We are looking for several experienced Quality Engineers to join an expanding medical device company commutable based in central Yorkshire. You will join a close-knit quality team and interact regularly with the production department.
Responsibilities:
* Providing quality engineering support to other areas within the business.
* Assisting with design verification and validation.
* Providing support to inspection teams.
* Providing support to process validation (IQ, OQ, PQ).
* Non- conformance investigations.
* Post-market assessment.
* Reviewing and approving design changes.
* Ensuring that processes and procedures are compliant.
* Assisting with standards reviews.
* Ensuring documentation and production records are compliant.
* Creation and approval of test protocols.
* Creation and review of technical reports and documentation.
* Lead cross function teams for improvement projects.
* Assisting in the completion of the Validation Master Plan.
* Auditing (internal and external).
* Equipment maintenance and calibration.
* Root cause analysis investigations.
* NCRs
* CAPA
* Compliant investigation.
Requirements:
* Educated to degree level in a relevant scientific or engineering discipline.
* Significant experience working in a similar role within the medical device industry.
* Experience with non-conformances, investigations, root cause analysis, risk analysis and CAPA.
* A good understanding of 21CFR820, ISO13485 and ISO14971.
* Excellent spoken and written English language skills.
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