Senior Quality Engineer

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.
• 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.

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.