Opportunity to work in a World class leading Medical Device facility
The key function of this role is to provide expert QA support to Operations.
- Supervision of Quality Technicians and QC Inspectors.
- 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).
- Provide effective and responsive QA support to Operations to meet their areas objectives of quality, cost and output.
- Drive and help to implement plant wide quality system improvements.
- Ensure Regulatory compliance in area of responsibility to cGMPs of all medical device regulatory agencies
- Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques).
- Approval of change requests for product, process and quality system changes.
- Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends.
- Validation: Define process and product validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
- Compilation of required Regulatory documentation (e.g. Technical files, Design Dossiers, Product transfer files, Essential requirements).
- MRB: Review of MRB trends and identification of appropriate corrective actions when required.
- Perform internal quality audits.
- Support the implementation of Lean Manufacturing across the site.
- Transfer and implement product and processes from development or from another manufacturing facility.
- Minimum of a Bachelor of Science Degree in Engineering/Technology.
- 3/4 years' experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated). Experience within a Med Device/Pharma environment i.e. FDA\ISO 9000 necessary.
- Demonstrate strong leadership skills and promote quality at source
- Develop plans and execute on time to these plans
- Strong Project Management skills combined with proven consistent execution within committed quality, time and cost targets.
If you would be interested in this role, or if you would like a further conversation click the 'apply now' button or email me on firstname.lastname@example.org.
The Quality market in Cork is currently very busy so if you would be interested in hearing what other opportunities are out there do get in touch and I would be happy to talk through.
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.