Senior Quality Systems Contractor
- Act as SME for internal auditing, CAPAs, complaint handling and supplier quality activities. Specifically, this will mean acting as CAPA Administrator for the site and assisting CAPA champions.
- Monitor progress of CAPAs and escalating any serious issues to senior management while also compiling monthly reports.
- Work closely with supplier quality, complaints and QA providing guidance and assistance as needed, implementing continuous improvements.
- Host monthly quality meetings to track actions and to liaise with product complaints, acting as the plant contact.
- Work cross functionally with design QA and Complaints to undertake health hazard assessments where needed.
- Act as SME for internal auditing and assist the internal audit team to plan audits and to coordinate corrective action plans.
- Provide assistance in training internal auditors with regard to relevant regulations.
- Analyse trends for CAPAs, Complaints, Internal Auditing and Supplier Quality KPIs
- Third level degree in quality or relevant discipline.
- Must have a good understanding and working knowledge of ISO 13485, FDA QSRs, JPAL and Canadian Medical Device regulations.
- Strong analytical skills.
- Five years or more experience in quality engineering, preferably quality systems.
- Lead auditor qualification is preferable but not required.
To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: email@example.com
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