The THOMAS Recruitment Group are recruiting on behalf of a global medical company based in South Wales. Our client is seeking a Quality Engineer to join their team on a permanent basis.
Duties will involve
- Offering pragmatic guidance on compliant routes to market that ensure robust documentary evidence and timely achievement of project goals.
- Provide regulatory and quality education and training where appropriate.
- Be the risk management authority on the project team to ensure that there is a favourable risk/benefit ratio and suggest plans and strategies for reduction of risk. Review and approve the risk management output.
- Develop the master validation plan for the introduction of manufacturing equipment and processes into production. Liaise with Manufacturing Engineers and operations to ensure that validation activities are planned, of sufficient depth and implemented effectively.
- Review and approve validation protocols including IQ, OQ and PQ, providing support for any statistical techniques and analysis required.
- Work with the Supplier Quality Engineer to ensure that the design supply base is sufficiently robust to ensure delivered product is compliant.
- Review and approve verification and validation documentation to ensure that design outputs meet input requirements and that user needs are met. Ensure that verification test methods have been adequately validated before use. Support the team to identify suitable test methods and validation approaches.
- Working closely with the design team, identify appropriate critical to quality features and generate first article inspection and goods receiving inspection plans, ensuring that appropriate measurement techniques are available.
- Review and approve all project related documentation that will be used to demonstrate compliance to regulatory requirements.
- Develop a professional working arrangement with the teams to promote quality values throughout.
- Responsible for verifying that project teams are operating in compliance with Medical Standard Operating Procedures for new product development.
- Identifying and reporting deficiencies to the teams and management in accordance with the non-conformance process.
Skills and Experience
- Must have previous experience in a Quality Engineering, Quality Assurance or Regulatory role in class II or class III medical devices environment.
- Must have sufficient knowledge of the following regulations to act as the subject matter expert within the development team: – ISO 13485 and/or FDA 21 CFR part 820, BS EN 14971.
- Working knowledge of ISO 10993, IEC 60601 ISO 11137 desirable.
- An understanding of process validation, process control and statistics cleanroom manufacturer, electronics manufacturing techniques desirable.
- Able to work to deadlines
- Training in ISO 13485 and/or QSR 21 part 820
- Training in risk management to ISO 14971
- Must show great attention to detail
- Must be reliable
- Good understanding of engineering principles and terminology
- Must be proactive
- Excellent people and communication skills
- Must have a sense of urgency in making things happen
- Good working knowledge of Office 365
The THOMAS Recruitment Group are an Employment Business. We supply temporary, contract and permanent staff to various companies throughout the UK to various sectors.
Located in South Wales, Midlands & the South West, we recruit for temporary and permanent job roles across the following core areas:
INDUSTRIAL | DRIVING | FMCG | PROFESSIONAL | ONSITE
If you are interested in this position, then please click ‘APPLY NOW’ below