Quality Assurance Manager

This European Medical Device organisation set up in Irelandover 15 years ago in Leinsterwith a strong diagnostic, nutritional and medical devices product portfolio. This Irish operation has since been established as this companies European Centre of Excellence specifically for Medical Devices and Nutritional products relating to Quality Assurance and Regulatory Affairs – Corporate Support function. Due to expansion, a new position has arisen for a QA Manager within their business in Dublin.

The Position

The Quality Assurance Manager is the main contact for quality related issues, product release requirements, corrective action/ preventive action programs, process improvement projects and compliance programs within the Medical Device section.

  • Works with project managers to develop project schedules and resource allocation models for QA related projects.
  • Ensures compliance to divisional, Corporate, MDD, ISO, etc requirements and maintains all QA related procedures.
  • Oversee Subcontractor Management & Auditing.
  • Overall Responsible for Quality Systems e.g. ISO13485 & 9001 compliance & audit programme.
  • Ensure successful completion of annual audit programme and carry out external audits (Quality Systems & GMP) if necessary.
  • Prepares quality documentation and reports by collecting, analyzing and summarising information and trends.
  • Implements ongoing quality improvement processes.

The Person

  • Degree in Science/ Pharmacy required. Postgraduate qualification is desirable.
  • A Minimum of 5 years experience in a Global QA Environment, preferably in Medical Device Sector.
  • Lead Auditor competence level.
  • Solid experience in Quality Systems ISO13485 & 9001.
  • Ability to lead and support several concurrent projects/products.

To learn more apply online or call Shane Browne on + 353 1 6321865

Salary: On Application Location: Dublin City Centre