Quality Engineer - Senior

  • Cork
  • Temporary 12 months
  • JO-1906-64594_1561549022

Summary

Responsibilities:

  • Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
  • Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
  • Conduct benchmarking to develop more effective methods for improving quality
  • Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
  • Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
  • Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.
  • Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
  • Supports new product introduction as part of design transfer.
  • Lead and maintain Material Review Board.
  • Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
  • Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
  • Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality
  • Partners with Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
  • Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes
  • If required - Approve IQ, OQ, PQ, TMV or Software Validation
  • Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes
  • Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
  • Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
  • Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.

Risk Mitigation

  • Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs
  • Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements

Requirements:

  • A minimum of a Bachelor's Degree, preferably in Engineering or related technical field. Requires 4-6 years related experience.
  • This position will require relevant experience working in manufacturing/operations.
  • In-depth knowledge of product/process Risk Management and experience with a proven track record of implementing appropriate risk mitigation.
  • Experience working in both an FDA and European regulatory environment is preferred.
  • Good technical understanding of manufacturing equipment and processes is required
  • Experience with a proven track record of implementing appropriate risk mitigation.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

Fastnet - The Talent Group
'Not Just Placers.........Partners'

The Life Science Specialists

By using this website, you consent to the use of cookies in accordance with the privacy policy Ok, got it