Quality Manager – Roscommon

This is an excellent opportunity for an experienced quality professional to join a leading medical device company.

Responsiblities:

  • Implementing an approach of Business Excellence and Continuous Improvement.
  • Identify areas for improvement and lead improvement initiatives.
  • Championing a structured approach to problem solving within the organisation.
  • Facilitate investigation, trouble shooting and reporting on system failures and product defects.
  • Ensuring release of product in accordance with approved procedures.
  • Maintenance of the plants ISO 13485:2003 / FDA 21 CFR Part 820 compliant Quality System.
  • Management of the Quality Assurance Function.
  • Management of the plant Corrective and Preventive Action systems.
  • Ensuring that products manufactured meet requirements of end users.
  • Auditing of the quality system.
  • Ensuring that all plant personnel are fully aware of quality requirements.
  • Review of customer complaints and device vigilance assessment.
  • Management of the company’s validation programme.
  • Complete internal and vendor audits to monitor the effectiveness of the quality system.
  • Maintaining records in accordance with the quality system requirements.
  • Maintaining the plants calibration programmes for test and inspection equipment.
  • Change control, deviation and the risk assessment activities associated with these activities.

Requirements:

  • BSc. in Quality/Engineering/Science discipline.
  • 5+ years People Management experience.
  • Experience in the medical device industry and excellent knowledge of ISO 13485:2003, FDA 21 CFR Part 820, and MDD 93/42/EEC
  • Ability to simultaneously manage a wide range of diverse activities.
  • Desire to own decisions and take responsibility for outcomes.
  • Must be commercial, understanding the revenue generating aspects of small business.
  • Some travel may be required.
  • Must be authorised to work in Ireland.

Please contact Emer Moore to discuss in confidence

00353578638188

emoore@emtechrecruitment.ie 

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