GXPeople have partnered with a Start-up Orthopaedic Medical Device Manufacturer in their search for a Quality Engineer. This is full-time role based on their site in Worcester.
About the job
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 ISO 13485 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:
- To be able inspect manufactured components to ensure that they meet the requirements of medical devices, and to be able to transfer these skills.
- To be responsible for the quality of released product and incoming product
- To 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.
- Management of metrology and CMM programming
- Responsible for qualification, maintenance, and calibration of inspection processes
- Perform root cause investigations to address non conformances
- Facilitate in the Implementation of corrective and preventive actions
- Facilitate in the Change processes
- Establish and report on quality objectives
- Perform supplier approval activities including supplier audits as required
- Manage SCARs as required
- Facilitate in process validations (including sterilization)
- Establish and maintain quality documents and conduct internal audits
- Assist the QA/RA Manager in other QA/QMS activities as required
- Accurate record keeping and good housekeeping.
- Clear and timely reporting of issues to QA and manufacturing leadership team.
- Ensure training record is kept up to date and modules completed on time.
Required Job Skills:
• Qualifications in quality, engineering or sciences to degree level
• Experience in quality engineering, quality assurance or similar role
• Experience in inspection processes and measurement technologies
• Experience of ISO 13485 or ISO 9001
• Internal auditor qualification ( Preferred)
• Medical device manufacturing experience
Please apply to this advert if this could be right for you or get in touch for more information.
