Telephone: 086 8395533
Senior Quality Systems Engineer
Our client, a medical device company in Westmeath is currently looking to recruit a Senior Quality Systems Engineer for their site.
The Snr Quality Systems Engineer will act as site SME for Internal Auditing, CAPA, complaint handling and supplier quality. This role will have work closely with the Supplier QE, QA Analyst (Complaints) and QA Analyst (Trending) and provide guidance and assistance as required. Assists in steering quality improvements within the plant working closely with all departments in the implementation of same.
- Act as CAPA Administrator for the site.
- Assist CAPA champions with documentation associated with CAPA system.
- Track progress on all CAPAs and escalate all issues to senior management.
- Host monthly CAB meetings, issue minutes and track action items to closure.
- Compile data for monthly GBU CAB meetings
- Liaise with product monitoring in relation to complaints (main plant contact)
- Ensure that failure investigation is completed in a timely manner in line with plant KPIs.
- Review and approval of complaints failure investigate reports
- Work with Design QA and product monitoring with respect to compilation of Health Hazard
- assessments where applicable.
- Act as SME with respect to Internal Auditing for the site.
- Assist the internal audit team with respect to planning/audit reports and corrective action plans.
- Ensure that internal auditors are trained and proficient with the applicable regulations.
- Co-ordinate the internal audit schedule and track progress to same on a weekly basis reporting
- progress and escalating issues to management.
- Provision of trending and associated metrics for all CAPS, Complaint, Internal Auditing and
- Supplier Quality KPIs.
- A third level qualification in quality or a related discipline. A good understanding ISO 13485, FDA QSRs, JPAL and Canadian Medical Device regulations is desirable for this position in tandem with strong analytical and computer literacy skills.
- Five or more years’ experience in a quality role (ideally quality systems)
- Lead auditor qualification preferred, not required.
For further information on this Quality Systems Engineer role in Westmeath please contact Bimi on 086 8395533 / email@example.com
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