JOB PURPOSE:
Act as a member of our clients quality team. To provide expert QA support to Operations, in ensuring operational goals and objectives are achieved for the plant.
KEY 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 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).
• 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.
• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Education/Experience/Skills
• Ideally will possess Bachelor of Science Degree in Engineering/Technology.
• 3/4 years experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated).
• Experience within a Med Device/Pharma environment i.e. FDAISO 9000 necessary.
• Excellent interpersonal and communication skills.
Experience/training in problem solving and process improvement methodologies.
Location Cork
Payment €45000 – €50000 per annum + VHI + Pension + Bonus
Terms Contract, Full-time
Company: Morgan McKinley
Contact: Andrew Curtin
Address: 6 Lapps Quay, Co. Cork
Tel: +35321 2300300
Email: acurtin@morganmckinley.ie
