Arcadis are seeking a Senior Quality Engineer for a long term contracting assignment at a leading medical device company in CorkOVERALL RESPONSIBILITIES:The role involves utilizing Quality Engineering tools and practices for the effective and efficient development and/or transfer of products/processes into commercial operations. The incumbent will also utilize Quality Engineering principles and problem solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve the capability of processes.POSITION DUTIES & RESPONSIBILITIES:Team member representing the Quality function supporting projects in with a focus on metals forming processes.Support Quality and Validation activities for process improvement projects, product transfers and new product introductions.Responsible for ensuring conformance with current equipment, process, and systems validation regulations.Determine the implications of validations upon; Product Quality, Patient Safety, and Data Integrity.Assess effectiveness of measurement tools, destructive tests, non-destructive tests (measurement system analysis).Determine process inputs and factors for variation where process capability is required.Responsible for conducting/reviewing Installation, Operating and Performance Qualification (IQ,OQ, PQ)s.Responsible for conducting Test Method Validations as requiredDevelop/Review Risk documentation to support processes as part of Validation processPartner with other cross functional partners to ensure the correct application of design controls, risk management and the investigation/correction of design failures/challenges.Conduct investigation, bounding, documentation, review and approval of non-conformances and CAPAs. Escalation of quality issues as appropriate.Support root cause analysis activities.Communicate effectively with internal team on actions and deliverables.Provide timely and accurate reporting and management of escalations as appropriate on project activities.Ensure all activities comply with GMP, ISO and quality system requirements.Ensure that all health, safety and environmental requirements are fulfilled.EDUCATION & EXPERIENCE REQUIREMENTS:ESSENTIAL:BSc in Engineering or Science with experience in a medium to high volume manufacturing environmentDESIRABLE:Experience working in both an FDA and European regulatory environment is preferred with an in depth knowledge of 21 CFR 820, CFR 11 and European regulations associated with the medical device industry.A thorough understanding of GMP/ISO and validation regulations.Technical training (Six Sigma Black Belt / Statistical Engineering) and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.Problem solving engineering expertise (Six Sigma, SE or A3)Strong verbal and written communication skills
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