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Details

Senior Quality System Engineer


Reference:KG-AGXC-854856 Location: Westmeath
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Job Purpose
Improve and maintain the quality management system in line with Medical Devices Directive and regulatory requirements applicable to the quality management system.

Key responsibilities will include (but are not limited to) the following:
- Quality system compliance to ISO13485, 21CFR 820, Medical Devices Directive and regulatory requirements applicable to the QMS
- Implement, maintain and improve quality systems including; CAPA, Management Review, Internal auditing, Supplier Management, Change Management and Document Control, Records Control and Training
- Coordinate and Support the Management Review process at a local, regional and global level
- Generate, interpret, analyze, and communicate results using management tools, graphs, and reports
- Provide inputs to KPI’s and Management Review
- SME for applicable QS Elements; NC, CAPA, Management Review etc.
- Audit facing SME for key Quality System Elements for all Regulatory and Corporate Audits
- Coordinate and support Audit Front Room and Back Room for Regulatory and Corporate Audits
- Actively coach the organization to support the effective implementation and maintenance of a compliant ISO system

Essential Skills / Experience
Engineering/Science degree/qualification – essential
Medical Device experience – essential
5/7 years of working within a Quality environment – essential
Lead Quality Auditor Certification – essential
Working knowledge of ISO 14971 - essential

If you would like further Information you can contact the recruiter directly:

Kevin Silke | Tel: +353 (0) 1 507 9255