Senior Quality Engineer/Medical Device/12 Month Contract

Essex  ‐ Onsite
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Description

Role Function

  • To act as the quality and regulatory interface between the QA Dept and the R&D department, with responsibility to:

- ensure project technical files are maintained according to the relevant
procedures
- to act as a "go to" person with regard to customer regulatory and/or quality
enquiries related to product design/formulation
- to work with the R&D team to ensure R&D activities are aligned to the
requirements of the QMS

  • To liaise with customers on questions of MDD/MDR/ISO13485/FDA and other national regulatory standards
  • To liaise with regulatory authorities with regard to CE submission files/FDA 510k submissions
  • To take ownership of agreed elements of the Quality Management System and to maintain them to ensure: -

- they remain relevant and appropriate to the business

- they reflect best practice

- they are compliant with all applicable quality and regulatory requirements

  • To lead and/or support internal audits to ISO 13485 and ISO 9001 standards and to work with other departments as required to close out related corrective actions.
  • To provide one to one coaching or training of small groups on quality assurance procedures as required.
  • To undertake supplier audits and to follow up and close subsequent improvement plans.
  • To support customer and regulatory audits
  • To undertake statistical analysis of production/supplier/customer data and to present findings at all levels of the organisation
  • To participate in and eventually lead root cause investigations of internal or customer related non-conformities.
  • To help address and correct customer concerns
  • To work openly and effectively with all levels of the organisation, so promoting a team approach in improving the quality of Contamac products and processes.
  • To support the QA department with any other projects and investigations required by the company.

Vivid Resourcing are committed to equality of opportunity for all applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships or any other characteristic protected by law.

Start date
01/08/2018
Duration
12 Month
From
Vivid Resourcing Ltd
Published at
10.07.2018
Project ID:
1595291
Contract type
Freelance
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