Hello,
My client is urgently in need of a Quality Engineer based in Hallow, Worcester due to expansion.
About my Client:
My client was previously a research and development company focused on bringing hip and knee arthroplasty concepts to a pre-commercialization stage. In 2023, my client was acquired by a strategic private equity firm and has transformed its focus to achieving regulatory approvals and commercializing transformative orthopaedic hip arthroplasty technologies in an elegant and time-efficient manner while maintaining the highest quality, regulatory, and manufacturing standards.
About the Role:
The Quality Engineer will be required to understand the processes and contribute to the continuous improvement of the production and development tasks whilst applying good manufacturing practice (GMP) and working within the QMS requirements. Your duties will involve the overseeing of quality of the implants and instrumentation of both goods manufactured in-house, and those which are manufactured by subcontractors.
Role Responsibilities:
1. Inspect manufactured components to ensure that they meet the requirements of medical devices, and to be able to transfer these skills.
2. Be responsible for the quality of released product and incoming product.
3. Ensure that the inspection systems and procedures fully satisfy the needs of the existing product, the demands of the process and the capabilities of those using the equipment and to ensure that the equipment is validated and used in the prescribed manner.
4. Management of metrology and CMM programming.
5. Responsible for qualification, maintenance, and calibration of inspection processes.
6. Perform root cause investigations to address non-conformances.
7. Facilitate the implementation of corrective and preventive actions.
8. Facilitate the change processes.
9. Establish and report on quality objectives.
10. Perform supplier approval activities including supplier audits as required.
11. Manage SCARs as required.
12. Facilitate process validations (including sterilization).
13. Establish and maintain quality documents and conduct internal audits.
14. Assist the QA/RA Manager in other QA/QMS activities as required.
15. Accurate record keeping and good housekeeping.
16. Clear and timely reporting of issues to QA and manufacturing leadership team.
17. Ensure training record is kept up to date and modules completed on time.
Requirements:
1. Qualifications in quality, engineering or sciences to degree level.
2. Experience in quality engineering, quality assurance or similar role.
3. Experience in inspection processes and measurement technologies.
4. Experience of ISO 13485 or ISO 9001.
5. Basic Health and Safety understanding.
6. Excellent attention to detail.
7. Ability to work as part of a team.
8. Adaptability and commitment.
9. Internal auditor qualification.
10. Medical device manufacturing experience.
Location: Hallow, Worcester
Salary: £30,000 - £35,000 dependant on experience.
PLEASE REPLY WITH YOUR LATEST CV TO BE CONSIDERED FOR THIS POSITION.
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