Boston Scientific Quality Engineer - P1 

Ireland, Cork 

932192420

Advancing possibilities for a brighter tomorrow

. To provide expert QA support to Operations, in ensuring operational goals and objectives are achieved for the plant.

Key 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 agencie(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, 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.

Educational Requirements

• 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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