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Quality Manager

  • Sector: Engineering
  • Contact Email: ranait.coughlan@collinsmcnicholas.ie
  • Job Ref: 19554

Quality Manager | Roscommon

We have a new opening for a Quality Manager to join a multinational MedTech company based in Roscommon. The successful candidate will be responsible for the management of the Quality Assurance & Quality Control department. Reporting to the Operations Manager, the successful applicant will manage multiple, complex projects and work effectively in a global environment.

Responsibilities:

  • Responsible for designing, updating, approving and implementation QMS SOPs
  • To Review, Approve and implement validation documentation, SMF, VMP, QM and other apex documents.
  • Ensure Periodic Self Inspections/Internal/ external Audit and MRM (Management Review Meetings).
  • To oversee and approve NCR, Customer Complaint, CAPA and Change control, Deviation ensuring continued compliance
  • To organize product recall if required per procedure.
  • Ensure environmental monitoring and testing is carried to GMP in line with documented procedure
  • Ensure that all appropriate suppliers are evaluated and listed on Approved Vendor List.
  • To approve RM / PM/ FP/ and stability Specification and Method of Analysis.
  • To review batch records and release of the batch.
  • Oversee document management process including change control process, document distribution, retrieval and archive.
  • Any other responsibility assigned to HOD and Management.

Requirements:

  • Bachelor’s degree in Engineering, Science or a related subject is desired but not essential
  • Lean Six Sigma Certification desired
  • A minimum of 5yrs in a similar role / Medical device industry is essential
  • Familiarity with ISO /FDA quality systems
  • Excellent communication, presentation, and customer relations skills
  • Strong team leadership skills.
  • Experience of all aspects of people management - objective setting, performance reviews,
  • Strong computer and document management skills
  • Ability to present an independent opinion and good presentation skills 

For a confidential discussion about this opportunity please contact Ranait Coughlan

ranait.coughlan@collinsmcnicholas.ie

(090) 6450664 (01) 66 200 88