Senior Quality Engineer

Ref. no.: MK/33760/IJP

Tags: Quality Senior Quality Engineer Senior Engineer Engineer Senior Quality Engineer

Location(s): Cork Cork city Munster

Salary range (€): Negotiable

Additional benefits:

Minimum experience required: 5 - 6 Years

Employment type: Permanent Full-time

Minimum qualification: Third Level Degree

Contact person: Michelle Kilcar

Contact e-mail: michelle@ccprecruit.ie

Job description:
Senior Quality Engineer


Key Responsibilities:

• Supervision of Quality Technicians and Quality Engineers
• 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: 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.
• Monitoring of key quality metrics in areas of responsibility to identify improvement opportunities.
  
  
  Education, Experience and Skills
• Minimum of Bachelor of Science Degree in Engineering/Technology.
• 4/5 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