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Quality Engineer - Medical Devices

Reference Number: 922205 | Salary: £30,000 - £40,000 | Location: Bedfordshire, United Kingdom | Division: Scientific Permanent


Quality Engineer – Medical Devices
Bedfordshire - £35,000 - £40,000

 

Our client is a worldwide leading manufacturer of components and solutions used in a range of businesses around the world. This client has been established for 80 years and has a strong track record in manufacturing excellence.


In support of the Quality Management System you will be required to apply quality engineering principles to address product and process issues. Lead and facilities complaint investigations and root cause analysis for effective preventative and corrective actions. Working to a range of quality standards such as: ISO13485, FDA 21 CFR 820, ISO14971 and MDD / EU Standards.


Responsibilities:

  • Support new product development (quality engineering, IQ, OQ, PQ, Risk Management activities) as the site subject matter experience on design control and PLM
  • Provide labelling, packaging and sterilisation validation support
  • Provide quality engineering guidance and support to site quality team in the execution of quality system, policies and procedures
  • Responsible for the application of risk analysis for both new design and product / process changes
  • Participate / conduct internal process pFMEA audits
  • Utilises risk tools such as pFMEAs, Hazard Analyses, Control Plans and Risk Management Plans / Reports
  • Support internal / external audits (FDA 21 CFR 820, ISO13485, ISO9001, customer assessments)
  • Provide training support on key quality management / assessment tools, procedures and specifications

Essential Qualifications:

  • Previous Quality Engineering experience in a Medical Device manufacturing industry in compliance with 21 CFR 820, ISO 9001, MDD and ISO 13485
  • Experience within Medical Device manufacturing would be a distinct advantage
  • Bachelor’s Degree in Engineering / Chemistry or Physics, Biology or Natural Sciences
  •  PC literate with good communication skills, both verbal and written. Minitab statistical analysis
  • The ability to work using own initiative when required, but also showing aptitude as a team player
  • Lean / Six sigma experience preferred

Additional desired skills, experience and qualifications:

  • Certified Quality Engineer
  • Risk Management – ISO 14971, ISO 13485 and ISO 9001

 

If this role is of interest please click apply now!

Harris Lord is acting as an employment agency

 

Keywords: medical devices, quality, qa, qa engineer, quality engineer, quality engineering, quality assurance, 13485, 14971, MDD, FDA, lean, six sigma, manufacturing, production, engineering 


Contact: Josh Hemsley

Keywords: Keywords: medical devices, quality, qa, qa engineer, quality engineer, quality engineering, quality assurance, 13485, 14971, MDD, FDA, lean, six sigma, manufacturing, production, engineering


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