Our client is a well-established international medical device organisation. Their innovative and forward thinking solutions to orthopaedic devices has made life easier for their patients. Due to continuous growth and innovation they require a Contract Quality Specialist to join their growing team at their Co. Waterford facility.
- Maintenance and control of Quality System
- Execution of Internal Quality Audits, issuance of audit reports
- Ensuring all product-based activities conform to procedures defined for such, including all projects in concept and development phase
- Carrying out; Risk analysis, FMEcA, Design Reviews, Design Verification, Design Validation, Biocompatibility, shelf-life testing, etc.
- Assessment and approval of vendors
- Issuance and receipt of controlled document revisions, maintenance of controlled documents logs, etc.
- 3 years' experience in a quality systems role, working to ISO 13485 standards in a Healthcare/Medical Device environment
- Quality assurance and Document control experience
- Experience in Design & Development activities under ISO 13485:2003 is a distinct advantage.
- Third level qualification in Quality, Science, Engineering, Materials or a related discipline plus evidence of QA expertise.
- Attractive Hourly Rate
- Possibility of Permanency
To learn more about this role apply online or contact Anna Carey on +353 21 4511193 for a confidential discussion.