Quality Lead /Manager

Medical Devices
Medical Devices
Dublin
Permanent
16013
Dublin
Permanent
16013

Want to join a new operation set up? Seeking to recruit a Quality Assurance professional for our clients in the Medical Devices Manufacturing sector. We are delighted to bring another exclusive position to the Irish Market. Our clients are a global leader in developing and manufacturing healthcare medical device products and are suppliers to over 80 countries worldwide with their products. They are still expanding their European base and setting up a small manufacturing facility here in Ireland to be located in North Dublin.

Role Brief

Seeking to recruit a candidate who is highly motivated, ambitious, and who is seeking a career step up into a Quality Assurance Management team long-term career. You will be starting within a small start-up facility environment so they are seeking a candidate who has ideally come from a small/medium-sized factory manufacturing environment who is hands-on in all aspects of QA/QC aspects and will be the quality function until they expand and develop a team. They are seeking a candidate at the Supervisor level who will have a career step up into a management role and given global support from the Head office and other sites.  This position will be responsible for managing all daily, weekly quality, and some RA activities to develop the company growth in Europe with support from global teams.


Duties and Responsibilities

  • Responsible for RA activities including product registration, compliance audits preparation and responding.
  • Be accountable for complaints, recall issues and carrying out the investigation.
  • Ensure to complete the documentation and activities of CAPA on time.
  • Oversee the compliance of document and data control systems.
  • Manage the execution of internal and external audits and ensure timely closure.
  • Implement an effective operator training and certification program. Also, manage the conduct of QMS training.
  • Lead improvement activity and Total Quality Control activities of the organization to success.
  • Plan and manage the annual budget.
  • Report the overall status of the Quality Management System in the meeting with Management or in other venues.
  • Comply with the regulations such as Walmart, EMC, RoHS, WEEE, REACH.
  • Provide the directions to the production floor and other QMS activities of the organization.

Qualifications

  • Bachelor’s degree in science, engineering or related field (Licensed pharmacist a distinct advantage).
  • 3+ years of management experience required or Supervisory level
  • 5-7 years’ experience in a manufacturing set-up, particularly in the medical device manufacturing company.
  • English business level speaker.
  • Strong knowledge of Iso 13485, FDA regulations, and other local and international regulatory requirements.
  • Excellent decision-making skills, strong leadership, and communication proficiency.

Our clients are seeking a candidate who is seeking a career step up into a manager role. We are seeking to speak with candidates who are in the supervisory or senior specialist level and have some management/ and or supervisory experience and or junior/mid-level managers seeking a new opportunity to join a start-up manufacturing facility with support from a global team.



For more information and a confidential discussion please contact Mary Mullin.

mary.mullin@collinsmcnicholas.ie

01 6620088 / 085 8718281

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Mary Mullin
Associate Director | Leinster