Excellent Senior Quality Engineering opportunity based South of the Tunnel
This opportunity is with a key player in the Medical Device space 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.
- 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 & utilization 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).
If this sounds of interest, or if you want to hear more, click the 'Apply now' button below and I will be in touch regarding your application
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.