Senior Quality Officer - Med Device
- Employer
- Barrington James
- Location
- Oxfordshire (GB)
- Salary
- Up to 50,000
- Start date
- 4 Nov 2019
- Closing date
- 4 Dec 2019
View more
- Discipline
- Quality, GMP, Regulatory Affairs, Labelling
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
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Job Details
Responsibilities will include:
- Supporting the Quality Assurance manager and working with all departments to ensure compliance to ISO13485 and maintaining accreditation.
- Supporting the QA manager with internal Audits and liaise with external suppliers to address matters of quality or compliance.
- Supporting the QA manager in dealing with Non-Conformances and CAPA’s
- Provide support during and prior to Notified Body audits.
- Devise and establish quality procedures, standards and specifications compliant with the ISO 9001:2015 standard which are lean with minimum administration.
- Positively engage employees with quality and its control processes and procedures.
- To ensure that we have a progressive and structured programme of future medical device development, adding value by increased efficiency and the accumulation of intellectual property
Skills and experience:
- A minimum of 3 years’ experience working as a Quality officer. Experience of working in a Scientific company is essential. Must have knowledge of ISO 9001, 13485 and 14971.
- A BSc in Biology or a similar subject.
- Day to day knowledge and maintenance of electronic Quality Management Systems
- Experience of developing and implementing the ISO 9001 quality management system and achieving formal accreditation/certification
- Background in Regulatory Affairs + Medical Devices experience
- Experience with medical device regulation in various markets such as US, China, Japan, Malaysia and Singapore.
- Knowledge of CE marking, GLP, GMP, MDD 93/42/EC and IVDD 98/79/EC would also be useful.
- A strong team player with the ability to engage, persuade, influence and negotiate with staff and managers.
Company
We’re great at what we do. A collection of the worlds finest Life Science recruiters working for the worlds best Life Science consultancy.
Originally, a purely contingency and contract recruiter, focused in the UK, Barrington James is now a sophisticated, highly effective provider of human resources solutions up to full RPO, partnering the pharma, medical devices, and healthcare industries right across the globe.
Company info
- Website
- https://barringtonjames.com/
- Telephone
- 01293 776644
- Location
-
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
GB
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