Quality Engineer

Ref. no.: 10500701

Tags: Quality Engineer GMP supervisor QA FDA Validation SPk ISO9001

Location(s): Cork

Salary range (€): 35000 - 45000

Additional benefits:

Minimum experience required: 3 - 4 Years

Employment type: Permanent Full-time

Minimum qualification: Third Level Degree

Contact person: Sam Bengtson

Contact e-mail: sbengtson@brunel.ie

Job description:  JOB PURPOSE

Act as a member of the 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 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

EDUCATION & EXPERIENCE

• 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. FDA \ ISO 9000 necessary
• Excellent interpersonal and communication skills

To apply for this position or for more information please contact Sam Bengtson on 021 2300 302 or email sbengtson@brunel.ie.