Our Worcester based client is a small autonomous business, working in friendly co-operation with respected orthopaedic surgeons, experienced engineers, and a variety of cutting-edge manufacturing facilities. They are offering an excellent opportunity for a Quality Engineer wiuth experience with Medical Devices experienve to join theit team on a permanent basis.
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 inhouse, and those which are manufactured by subcontractors.
Duties & 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.
Requirements
- 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
- Basic Health and Safety understanding
- Excellent attention to detail
- Ability to work as part of a team
- Adaptability and commitment
- Internal auditor qualification
- Medical device manufacturing experience