Snr Quality Systems Engineer required for our client, a multinational medical device manufacturer based in the Midlands.
As the senior quality systems engineer you will be responsible for all quality systems activities across the site acting as SME for internal auditing, CAPA and supplier
This is a contract role based in Westmeath.
Your new job
Key duties & responsibilities:
- 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
What are we looking for?
- 3rd level qualification in Quality with Medical Device experience.
- Expert knowledge of FDA, ISO 13485, QSRs and auditing.
- Exceptional problem solving and analytical skills and proficient at multitasking.
- Strong computer skills (MS Excel, PowerPoint etc).
- Attention to detail and the ability to meet required deadlines in a timely fashion.
- Excellent communication skills and strong teamwork capabilities.
Apply for this job now or get in touch with Michéal on 090 6490485.
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