- BBBH783910 Jun 01, 2021 Competitive
An excellent opportunity for a Senior QA professional to join one of Cork's leading employers. You must be a passionate about compliance and people leadership.
This opportunity is with a key player in the Medical Device space and is based South of the tunnel. The key aim of this role is to provide expert QA support to Operations, in ensuring operational goals and objectives are achieved for the site.
The ideal candidate will have a Level 8 qualification in Engineering or related technical/Quality discipline and 4 + years in a GMP environment, ideally working to ISO 13485 standardisation. This role is based in a manufacturing environment and will have a number of direct reports. Cross collaboration, excellent communication skills along with demonstrated leadership ability is essential for this role. Experience within operations and with process/equipment validation and change controls is highly advantageous.
- Supervision, coaching and mentoring of Quality Technicians and Quality Engineers.
- Lead, in conjunction with production and engineering functional Seniors, a production core team to achieve plant targets across Quality, Service and Cost.
- Act as CAPA Mentor ensuring CAPAs identify root cause and effective solutions and are completed in compliance with regulatory and procedural requirements
- Ensure team is focused on appropriate trending, investigation, root causing and corrective action of non-conformances & customer complaints.
- Use problem solving expertise to drive root cause identification for process and product issues
- Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
- Approval of change requests for product, process and quality system changes.
- Identification & utilisation of key quality metrics in areas of responsibility to identify improvement opportunities.
- Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities). Drive and implement plant wide quality system improvements.
- Define process and product validation requirements. Validation protocols and reports approval.
- Ensure Regulatory compliance in area of responsibility to cGMP's of all medical device regulatory agencies (e.g. FDA and TUV).
- Review of MRB trends and identification of appropriate corrective actions when required.
If this sounds of interest, or if you want to hear more, click the 'Apply now' button or reach out to Kellie on firstname.lastname@example.org
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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Senior Consultant | Engineering Recruitment - Quality & Validation
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