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Senior Quality Engineer - West Yorkshire, United Kingdom - Kinetica UK Ltd
Description
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.
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.
Risk management.
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.
NCRsCAPACompliant 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 communication skills.
Excellent spoken and written English language skills.Ability to work autonomously.
Strong project management skills.
Good attention to details.