Senior Quality Engineer
Contract – 12 Months
We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
· 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.
· 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
· Supports new product introduction as part of design transfer.
· Conduct investigation, bounding, documentation, review and approval of nonconformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
· Approve IQ, OQ, PQ, TMV or Software Validation
· Partners Global 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.
· Conduct stakeholder analysis to ensure that customer CTQs are known and
adequately addressed in control plan
· 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.
· 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
Experience and Education: