Jobs

Quality Engineer

We offer 25 days holiday a year (with extra days for long service), a matched contributory pension scheme, private healt - Quality
Ref: 328 Date Posted: Monday 14 Oct 2019
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Our Client is a world-class innovation, design and product development consultancy with a driven purpose to design a better world. They have a strong track record of delivering successful products and experiences for clients in medical, consumer and industrial sectors. To support the growth and ambition of the business, they are looking for a Quality Engineer to join their exceptional design, development and quality management teams.

 

We are looking for a motivated individual with significant experience of Quality Engineering within the medical sector.

Responsibilities:

  • Translation of regulatory requirements into product requirements
  • Ensuring compliance with relevant standards and regulations
  • Responsibility for risk management activities in line with ISO 14971 and design verification
  • Development of key regulatory documents such as design inputs, and design reviews
  • Review of requirements for traceability
  • Planning verification programmes including establishing acceptance criteria and sample sizes
  • Understanding clients’ QMS processes and ensure our team are working to them, where necessary
  • Performing analysis and interpretation of test data, including statistical analysis, where necessary
  • Supporting client audits
  • Supporting the creation and reviewing of Technical Files / DHFs
  • Reviewing clients’ documentation in line with in house SOPs and regulatory requirements
  • Review of small batch production work instructions and processes to ensure quality assurance
  • Interpreting and responding to feedback from the FDA with regards to device submissions
  • Responsibility for regulatory intelligence monitoring
  • Knowledge and application of implementation of key standards

Your Skills and Experience

• 10 Years’ experience in Medical Device Development

• Knowledge of medical device regulation in key market (US and EU)

• Degree in engineering or related technical discipline

• Experience of risk management regarding medical product development ISO14971

• Understanding of medical device directive 93/42/EEC, ISO13485 and FDA QSR

• Experience of design verification

• Knowledge and experience of implementing IEC 60601 and IEC62304

Specialists in consultancy


At Medical Engineers we have a range of technical consulting jobs in the medical engineering industry throughout the UK. Requiring a broad range of technical and management skills and most importantly the ability to communicate effectively. Consultancy roles require candidates with unique abilities. Roles vary in length of contract depending on clients’ requirements.

Our degree qualified consultants have specialist knowledge of the UK medical engineering consultancy job market. We have a successful track record in finding the best candidates for our clients who know and trust Medical Engineers to understand their business requirements.

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