- 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.
- NCRs
- CAPA
- Compliant investigation.
- 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.
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Senior Quality Engineer - West Yorkshire, United Kingdom - Kinetica UK Ltd
Found in: Appcast UK C C2 - 5 days ago
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. You will join a close-knit quality team and interact regularly with the production department.
Responsibilities:
Requirements:
