Quality Engineer

· 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

Quality Operations

• 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.
  
  Essential


• 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


Desirable

· Internal auditor qualification

· Medical device manufacturing experience,
• Quality assurance: 1 year (preferred)
  
  · £30,000 - £35,000 p.a. depending on experience and qualifications


· Pension

· 20 + days annual leave, plus Bank Holidays

· Death In Service Benefit

· Free on-site parking

Job Types: Full-time, Permanent

Pay: £30,000.00-£35,000.00 per year

Benefits:

• Company pension


• Cycle to work scheme


• Free parking


• Health & wellbeing programme


Schedule:

• 8 hour shift


• Monday to Friday