Quality Engineer - Medical Devices

Job details

Quality Engineer: This highly professional medical devices organisation is looking for a Quality Engineer to take responsibility for the implementation of Quality Engineering activity in strict accordance with company procedure and quality requirements.

Quality Engineer: Key responsibilities:

• Take responsibility as a project member, providing quality engineering and regulatory expertise to ensure compliancy with ISO13485, FDA 21 CFR Part 820, MDD 93-42-EEC, ISO60601
• Assist the project manager in making certain all necessary requirements of project phases are identified and completed
• Review and approve of all quality related documentation, in particular approval of URS, S/W design specification, SATs protocols and reports, code reviews and other project related documentation
• Provide quality engineering support in other areas of projects, operations and process analysis
• Take a key role in ensuring risk analysis are updated and ISO 14971 compliant
• Support on site CSV activity

Quality Engineer - Key qualifications, skills and experience:

• Background in engineering with a HND or equivalent qualification in engineering, science or technology discipline
• Proven track record in a quality related field
• Exceptional communication skills, both written and verbal
• Medical Devices (ISO 13485) knowledge
• Strong metrology skills and understanding of inspection techniques
• Ability to interpret technical drawings

We are looking to speak with a highly dedicated and ambitious Quality Engineer to join this outstanding company.

Apply now, send a full CV to p.rabey@x4group.co.uk or call Peter on 020 7836 3942 for more information.