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Job ID: JOB-13513

Quality Engineer II

Location: Cork

Permanent

We have an exciting opportunity for a Quality Engineer with our Client in Cork to join a Global leader in the medical device industry. They are looking for candidates coming from a highly regulated background (Automotive, Aerospace, Pharmaceuticals & Medical Devices) with experience in a high volume manufacturing facility.

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).
• 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.

 Required Qualifications:

• 2-3 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

Preferred Qualifications:

• Previous experience in a Quality, or Manufacturing background.
• Experience in the medical device industry.
• Working knowledge and understanding of FDA, ISO13485, and the medical device industry quality requirements associated with manufacturing and supplier controls.
• Experience in problem solving and process improvement methodologies.
• Process Validation, Risk Management, CAPA experience.

Julie Curran

JOB-13513

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