Senior Quality Manager

Role Type: Full-Time, Permanent

Location: Bristol, United Kingdom

Application Opens: 04/03/2019

Application Closes: 18/03/2019 08:30 am

Salary: £40k-£50k, dependant on experience + benefits

Job Start Date: ASAP, dependant on availability, target start date of: 20/05/2019

Required Qualifications: BEng, BSc or BA degree in quality management or other relevant area

Please note: Only applicants that can legally work in the UK at the time of application will be considered.

Role Specification

We are looking for a Senior Quality Manager to implement, manage, and oversee the company’s quality management system. Open Bionics is a Bristol-based startup that designs and manufactures bionic limbs for amputees. The company has won several awards and just this year was named by Fast-Company as the 6th most innovative company in the whole of Europe. The company is scaling rapidly and is seeking a Senior Quality Manager to maintain high quality standards across the business including product design and development, manufacture, marketing, training and compliance.

Key responsibilities include:

  • Running Open Bionics’ quality management system in compliance with BS EN ISO 9001: 2015, BS EN ISO13485: 2016, MDD 93/42 EEC, CMDCAS 13485, FDA 21 CFR part 820.
  • Improve internal quality processes and checks within production to ensure best in class products are shipped.
  • Point of contact with regulatory bodies such as MHRA and FDA.
  • Oversee product certification and Technical File maintenance.
  • Manage post-market surveillance and vigilance activities.
  • Manage Notified Body relationships and interactions with other regulatory/government bodies (e.g. FDA, EMA, NICE, etc.).
  • Internal audit responsibility.
  • Keep abreast of quality and regulatory latest developments.
  • Manage, supervise and maintain excellent technical files, quality systems and processes, coordinating all functions of the business.
  • Management of non-conformances including the raising of them, closure of open action and taking remedial action.
  • Being the conduit for communicating changes internally and externally, and for formal updates to product registrations.

Person Specification

Desirable attributes include:

  • Excellent risk-based decision making skills.
  • Good at overseeing policies and procedures.
  • Able to “see the bigger picture” and prioritize lower level work accordingly.
  • Strong written and verbal communication skills.
  • Self motivated and responsible.
  • Reliable.

Scorecard

Role Specification

  • 5+ Years experience in quality management
  • Practical experience working to and applying ISO13485
  • Experience working in a company that manufactures medical devices
  • BEng, BSc or BA degree in quality management or other relevant area
  • Certified Internal Auditor

Person Specification

  • Good written communicator
  • Enthusiastic to make an impact
  • Enjoys working in startups