An exciting Quality Engineer role has arisen with a leading global medical device client in Cork.
Key Roles & Responsibilities:
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 area's objectives of quality, cost and output.
Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA's).
Drive and implement plant wide quality system improvements.
Ensure Regulatory compliance in area of responsibility to cGMP's of all medical device regulatory agencies (e.g. FDA and TUV).
Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
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).
Education & Experience:
2-5 years’ experience in Manufacturing or Quality with a Level 8 qualification in Engineering or related technical/Quality discipline.
Excellent written and verbal communication skills
Demonstrated ability to work with cross functional organizations in a dynamic manufacturing environment to solve problems
Strong command of MS Office – Word, Excel, PowerPoint.
Ability to rapidly learn and use new applications
For a confidential discussion and more information on the role, please contact Kevin Griffin
Kevin Griffin
kevin.griffin@collinsmcnicholas.ie
(021) 2427108