Medical Devices JobsQA Manager

  • SJ50180
  • Permanent
  • Mayo, Sligo

Collins McNicholas

Quality Assurance Manager

Role provides Quality leadership for the manufacturing division which includes the necessary monitoring, feedback and corrective action mechanisms to ensured continued compliance to both system provisions as well as product (device) requirements.

The primary objectives with the role include; 

  • Lead and develop the Quality Team
  • Develop and advise on the development of quality systems and procedures within the plant and support of global quality procedures.
  • Provide leadership in change management and risk assessment.
  • Conduct, lead, or direct product complaint investigations.
  • Participate in the Internal audit program
  • Provide project leadership for implementing continuous improvement projects
  • Provide leadership and resources for raw material inspection, in process inspection and verification and release of finished goods into distribution
  • Provide leadership and resources for validation testing, maintenance and calibration of test equipment.
  • Ensure team is trained to FDA QSR, ISO 13485 / 14971 and MDSAP requirements.
  • Support External Audits
  • Serve as back-up to QA Manager
  • Quality Metric reporting and support for Management reveiw

To successfully fulfill the above objectives you should be competent in the following areas; 

  1. Personnel Staffing and Management
  2. Problem Solving and Analyzing
  3. Project Managing (includes AFE process)
  4. Fiscal Managing (includes budget preparation)
  5. Goal Setting
  6. Communicating/Leading
  7. Processes Improvement
  8. Auditing
  9. Change management

10 years experience in a quality engineering/systems role including people management experience is desired with a degree qualification in Engineering, Science or Quality. 

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Please contact Davin at Collins McNicholas to discuss further 

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