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Job Details


Quality Engineer - CONTRACT (Contract)

Location: South Wales  Country: UK

Quality Engineer/Quality Consultant - Contract

Key: Medical Devices, Quality Engineering, Product Introduction

Duration: Initially 6 months

Rate: Negotaible per day

Location: South Wales

Our client is seeking an experienced, pro-active and motivated Quality Engineer to join our clients' market leading organisation. The successful candidate will promote a proficient, hands on approach whilst effectively supporting compliance to regulatory requirements through focusing on quality, service delivery, cost and efficient process control.

Your new role:
*To be responsible for verifying that project teams are operating in compliance with the businesses Standard Operating Procedures for new product development.
*Offering pragmatic guidance on compliant routes to market that ensure robust documentary evidence and timely achievement of project goals.
*Develop a professional working arrangement with the teams to promote quality values throughout.
*Provide regulatory and quality education and training where appropriate.
*Identifying and reporting deficiencies to the teams and management in accordance with the non-conformance process.
*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.
*Review and approve all project related documentation that will be used to demonstrate compliance to regulatory requirements.
*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.
*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.
*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.

What you'll need to succeed:
*Degree qualified in an engineering, medical or other relevant subject
*Training in ISO 13485 and/or QSR 21 part 820
*Training in risk management to ISO 14971
*Must have previous experience in a Quality Engineering, Quality Assurance or Regulatory role in class II or class III medical devices environment.
*Experience of supporting new product development teams in a quality role
*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
*Attention to detail
*Excellent people and communication skills
*Excellent Problem-solving skills
*Good understanding of engineering principles and terminology
*Good working knowledge of Office 365

By applying to this advert you are giving CPS Group (UK) Ltd authority to hold and process your data for this specific role and any other roles we may deem suitable to you over time. We will not pass your data to any third party without your verbal or written permission to do so. All incoming and outgoing calls are recorded for training and compliance purposes. CPS Group (UK) Ltd is acting as an Employment Agency in relation to this vacancy. Our new privacy policy can be found on our website

Posted Date: 17 Oct 2019 Reference: JS-J17429 Employment Business: CPS Group (UK) Ltd Contact: Mark Brereton