Quality Engineer

Fastnet The Talent Group

Cork

Quality Engineer. The successful candidate will be responsible for conducting assignments encompassing complete projects or portions of major projects. Role. 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. Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc. 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. Supports activities related to the Material Review Board. Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate. Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing. 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. Approve IQ, OQ, PQ, TMV or Software Validation. Partners with 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. 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. Requirements. Degree Qualification in relevant Engineering or Science discipline. 3 years' experience in Quality Engineering or similar role Medtech or other highly regulated industry. 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. This job originally appeared on RecruitIreland.com.

2375 days ago