Our leading client based in Co. Cork are looking to hire a contract Quality Specialist to provide expert QA support to Operations, in ensuring operational goals and objectives are achieved for the plant.Key Roles & Responsibilities:Supervision of Quality Technicians.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 notices for product, process and quality system changes.Validation: Define process, product and test method 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.Education & Experience:Minimum of Bachelor of Science Degree in Engineering/Technology.2/3 years’ experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated).Experience in the medical device industry is an advantage.Experience on an automated/high volume line an advantage.
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