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Quality Engineer II

Job Title: Quality Engineer II
Contract Type: Permanent
Location: Cork
Industry:
REF: 89081
Job Published: about 2 months ago

Job Description

Contact: Bimi Felix
Email: bimi@hero.ie
Telephone: 091730022

Quality Engineer II
Our client, a medical device company in Cork are currently looking to recruit a Quality Engineer II for their site.


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.
Educational Requirements:
  • Minimum of a 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.
  • Demonstrate strong leadership skills and promote quality at source
  • Develop plans and execute on time to these plans
  • Strong Project Management skills combined with proven consistent execution within committed quality, time and cost targets.
  • Experience/training in problem solving and process improvement methodologies (Engineering Essentials TM).
For further information on this Quality Engineer II role in Cork please contact Bimi Felix on 091730022 / bimi@hero.ie
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