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.
- 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.
- 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
(090) 6450664 (01) 66 200 88