Quality Manager - Medical Devices

Slough  ‐ Onsite
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Description

The Quality Manger role will be responsible for the successful day-to-day operation of the Quality Management system, supporting and leading quality improvement initiatives. A key responsibilities will be to lead continuous improvement activities as well as develop and execute the internal audit program.

DUTIES AND RESPONSIBILITIES

These will include the following listed below and other duties may be assigned depending on the needs of the business:
  • Organise, develop and maintain the Company Quality activities in accordance with the Company Quality Assurance system.
  • Representative for ISO13485 and 21CFR820
  • Maintain a full accreditation under current and foreseeable EU and FDA Directives for medical devices.
  • Plan and manage all internal and external audit processes.


To manage day to day Quality control activities.
  • To manage each project in conjunction with other departments including projected deadlines.
  • To manage the day to day running of the Quality Management System, CAPA system, complaints system, non-conformance system, validation systems, supplier approval, audit and monitoring system
  • To lead root cause analysis and non-conformance investigation activities, lead validation activities, critical process change activities, complaints handling and all sterilisation and microbiology activities
  • To chair monthly and annual Management Review Meetings, the Validation Steering Committee and the Supplier Management Committee
  • To attend the Material Review Board (MRB) meetings, Audit Planning Committee meetings and Change Control Committee meetings
  • Record preventative Actions and Product Recall Activities
  • Maintain quality records, sterilisation records including bio burden and maintain archive and traceability of products.
  • Approve incoming material certificates and manage overall process.


PERSON SPECIFICATION

Essential:
  • Strong Quality Assurance background - working within the medical industry
  • Thorough understanding of CE marking, EU device directives and FDA Working with the FDA Education and qualifications
  • Lead Auditor experience


For more information on this role please get in touch with Oliver Davies on or follow the attached hyperlink for further information https://uk.linkedin.com/in/medicaldevicesqara
Start date
04/2016
From
Real Staffing
Published at
23.02.2016
Project ID:
1076702
Contract type
Permanent
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