QA/RA Specialist - South West - £45,000

South West England  ‐ Onsite
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Description

My client is a large medical device company in the south west that is now looking for an RA/QA Specialist to join their team. £40-45,000.
  • Assure the maintenance, continuance and control of a Quality Management System according to international standard ISO 13485, European Medical Device Directive (MDD) 93/42/EEC, and corporate guidelines/policies in the UK
  • Assure an effective, consistent and reliable forward of information in terms of product surveillance on the local market in accordance with legal requirements (e.g. MDD) and procedures.
  • Surveillance and forward of information concerning changes and/or new upcoming local legal requirements to assure the continuity of companies business.
  • Represent the Quality Assurance and Regulatory Affairs Functions within UK.
  • Implementing, development, maintenance and control of a Quality Management System according to ISO 13485 and corporate guidelines/policies.
  • Manage customer complaints handling.
  • Support instructed actions e.g. product blockings, recalls, provide field safety notices.
  • Responsibility for product registration on the market in accordance with local legal requirement; main contact for the UK competent authority and responsibility for the maintenance of the business in the local market regarding authority's demands.
  • Initiation of internal and external audits; also cooperation within an internal auditor team coordinated by headquarters.
  • Continuous communication with QA/RA EMEA team.
  • Advise general management and work close together with other departments of ZOUK to support the business in the county as far as principles allow.
  • Involvement in special projects and special duties like (re-)validation of technical systems and procedures.
  • Represent companies interest in national associations or similar organizations. Involvement in task forces of such organizations if necessary.

Essential Requirements;
  • Knowledge of UK medical device regulations
  • 2-3 years experience in a similar role within a Medical Device company.
  • Ability to function independently without extensive oversight and extensive local quality organization
  • Experience in leadership and teamwork
  • Ability to prepare high quality, clear communication materials tailored to the appropriate audience
  • Discretion and confidentiality
  • Experience in Quality Management and verifiable experience in Quality Assurance, engineering or validation
  • Qualified auditor/lead auditor preferred


If you believe you have the correct experience then please send me your CV and I will be in touch shortly.
Start date
06/2015
From
Real Staffing
Published at
20.04.2015
Project ID:
888598
Contract type
Permanent
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