​Quality Engineer

Salary DOE

Newport

A new opportunity has been created to play a key role in an innovative and dynamic medical device manufacturing business that is operating at the cutting edge of its field and developing next generation products that save lives. The company offers security, flexibility, autonomy and a varied and rewarding role.

This is what you’ll be doing

You’ll will provide support for the design, development and manufacture of medical devices, carrying out quality engineering processes and the generation, review and approval of records and ensure compliance with ISO 13485 and FDA regulations, contributing towards the successful creation and delivery of an expansive range of life saving medical devices.

Key responsibilities include:

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• Verifying that project teams are operating in compliance with NPD SOPs.

• Offer guidance on compliant routes to market that include robust documentary evidence and timely achievement of project goals.

• Develop a professional working relationship with teams across the business, promoting quality values throughout.

• Provide regulatory and quality education and training support.

• Identify and report deficiencies and non-conformances to the teams and management.

• Provide risk management support

• Develop the master validation plan for the introduction of manufacturing equipment and processes into production; liaising with Manufacturing Engineers to ensure the validation activities are planned and implemented effectively.

• Review and approve IQ/OQ/PQ protocols, providing statistical analysis support.

• Work with Design to identify critical quality features, generate first article and goods receiving inspection plans.

• Review and approve verification and validation documentation

The experience you’ll bring to the team

• Previous experience in Quality Engineering, Quality Assurance or Regulatory role within medical devices.

• Experience in Class II or Class III medical device environment is advantageous.

• Strong knowledge of ISO 13485 and/or FDA 21 CFR part 820, and BS EN 14971

• An understanding of process validation, process control and statistics.

• Experience of electronics manufacturing techniques is advantageous

And this is what you’ll get in return

• A market leading salary, dependant on experience

• Flexible working hours and the ability to work from home

• Private medical

• 25 days holiday + bank holidays

• 5% employer contribution pension

• The opportunity to work with a highly skilled and motivated engineering team in one of Wales’ most exciting medical device businesses

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Are you up to the challenge?

If you feel you have the skills, experience and passion to be successful in this role apply now. 

*Please note, whilst we do our best to contact all candidates, due to the high number of applications we receive we cannot guarantee this for every role. If you have not heard anything from us within 7 days of applying - then unfortunately you have been unsuccessful. Please keep an eye on our website for more opportunities.