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