Quality Manager

Recruiter
Osborne
Employment Type
Permanent
Salary
€90,000 per annum
Osborne logo

Our client, a medical device manufacturer based in Dublin, is seeking a Quality Manager to join their growing team. 

The successful candidate will report directly to the Head of Quality & Regulatory Affairs and liaise with regulatory notified bodies. At site level you will lead and manage a small site based team currently consisting of 1 direct report which will grow as the company evolves . The successful candidate will need to be a team player that can operate within a small company environment making effective decisions efficiently .

Responsibilities:

  • Responsible for the implementation and maintenance of the Quality Management System in line with applicable regulatory requirements including EN ISO , MDD 93/42/EEC, MDR 2017/745 and FDA 21 CFR820
  • Manage and mentor direct report/s
  • Assist in the CE marking of new and approved devices and potential FDA approvals
  • Responsible for production batch release
  • Manage the Complaints System and drive complaint investigations to ensure complaints are closed out in a thorough and timely fashion
  • Manage the CAPA System and drive CAPA investigations to ensure CAPA’s are closed out in a thorough and timely fashion
  • Manage the Internal Audit System to ensure audits are performed on time and that associated non-conformances are closed out in a timely fashion. Perform internal audits as required
  • Manage the activities associated with Vendor Qualification and ongoing monitoring of such. Performance of Vendor Audits and timely resolution of vendor issues
  • Management of the Documentation Change Control System
  • Oversight and management of the Validation and Requalification schedules on-site
  • Management of the Management Review process including scheduling, compilation of data and presenting such data at the Management Review Meetings. Document associated minutes and ensure thorough and timely closure of associated action items
  • Manage the coordination of activities in preparation for and during external audits such as regulatory audits and customer audits and assist with the hosting of such audits as required
  • Manage the Continual Improvement Process on site including the annual review and assignment of site KPI’s and Quality Objectives. Collate and report on such on a monthly basis
  • Manage and present monthly Quality Update/KPI Trend Meetings
  • Manage the Deviation System
  • Coordinate Risk Management activities in line with EN ISO 14971
  • Provide Quality Training as needed including annual GMP training and induction training
  • Ensure all Quality-related projects are completed according to agreed deadlines and timescales
  • Perform additional duties as required within the role of Quality Manager as directed by the Head of Quality and Regulatory Affairs

Essential Requirements :

  • Educated to Degree level in a Science (Chemistry, Microbiology or Quality Assurance) or Engineering discipline
  • A minimum of 5-7 years’ experience working in a Senior Quality Role in a Medical Device Environment with CE approved products
  • Experience in managing and working with medical device regulations and standards including EN ISO , EN ISO 14971, MDD 93/42/EEC, MDR 2017/745 and FDA 21CFR820
  • Previous people management experience
  • Qualified internal auditor trained to Lead Auditor level
  • Excellent cross-functional communication skills and attention to detail
  • Excellent written, organizational and computer skills
  • Ability to work with cross functional teams on multiple projects in a fast-paced environment
  • Self-motivated with the ability to deliver independently

Desirable Requirements :

  • MDR 2017/745 training and experience
  • Experience of aseptic processing
  • Sterilisation experience
  • Direct involvement in regulatory submissions to regulatory bodies such EU Notified Bodies and the FDA
  • MDSAP training and experience

For more information please apply through the link provided for the attention of Lisa hughes or call Osborne Recruitment on

If you are interested in finding out more about the above role and would like to be considered other suitable roles that we may have available for your skill set – please attach your CV via the link provided
Please submit your updated CV in Word Format

If you are living in Ireland and hold a valid work permit we would love to hear from you, if however you do not hold a valid work permit unfortunately we will not be in a position to assist you with your job search.