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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