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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)

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
Telephone
01293 776644
Location
Victoria House
Consort Way
Horley
Surrey
RH6 7AF
GB

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