Lead Quality Engineer

Lead Quality Engineer

Elvie

Bristol, United Kingdom

Who you are

We are looking for a Lead Quality Engineer. You are a detail-oriented, passionate and dynamic individual with a desire to lead the Quality Engineering team. You respect rules and regulations but are not afraid to do things differently and challenge ‘business as usual’. You are able to understand the needs and challenges of the cross-functional teams that successfully drive products to market; from R&D and Product Development, Operations, Manufacturing, Sales and Marketing. You are organised and logical and can form a clear path through the noise when complex decisions need to be made. You can develop plans of action and communicate them with confidence to 3rd party suppliers and the different functions within the business.

You're a quality engineer with at least 6-8 years of experience, and have been working within the Medical Device industry in a Quality and Regulatory focused role. You are excited by the prospect of defining the gold standard for quality, design documentation and document control in a rapidly growing business.

The Day to Day of the role:

Manage the Quality Engineering team, projects to timelines and budget:

  • Activity and resource planning: work out what needs to be done, by who and when
  • Coach and mentor the quality team

Product and Process Improvement:

  • Work closely with our Customer Care to recover and correctly interpret insights from the field
  • Help define proposed improvements with our Engineering team and implement proposed improvements with our Manufacturing teams through ECO’s
  • Help drive improvements and to create a proactive and functional eQMS with a value-added approach to Quality Management Systems

Set the Gold Standard:

  • Document change control day to day
  • Day to day administration of the general requirements of the QMS
  • CAPA, SCAR and NCR investigation and administration
  • Review of design and development processes
  • Maintenance of calibration activities and records
  • Carry out internal and external audits when required
  • Supplier approval and the associated duties involved in supplier control

Requirements

What we need from you:

  • You're a quality engineer with at least 6-8 years of experience, and have been working within a highly regulated environment. Medical device industry experience would be a benefit
  • Previous experience leading junior engineers would be of benefit
  • A degree in a relevant engineering, design or science discipline (or equivalent qualification)
  • Appreciation for all stakeholders involved in new product development
  • Experience in consumer or medical products design and manufacture would be of benefit
  • Developing Quality Management Systems and the ability to interpret regulations
  • Experience ensuring a high level of compliance with MDD 93/42/EEC Medical Devices Directive, MDR, ISO 13485, 21 CFR 820, and cGMP
  • Experience in CAPA investigation and root cause analysis
  • Knowledge of Risk Analysis ISO 14971:2012 and IEC60601-1 would be an advantage
  • Experience auditing to ISO 9001 or ISO 13485 would be an advantage
  • Able to review and understand hardware, firmware and software requirements and specifications
  • Must be familiar with commonly used productivity & statistical software as well as eQMS software

Apply Now

Don't forget to mention EuroEngineerJobs when applying.

Share this Job

More Job Searches

United Kingdom     Biomedical Engineer     Industrial Engineer     Elvie    

© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies