We have an exciting new role for a Quality Engineer based in Kildare.
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.
They will utilize appropriate risk management to prevent unanticipated failure modes and improve the capability of processes.
POSITION DUTIES & RESPONSIBILITIES:
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Team member representing the Quality function supporting projects with a focus on metals forming processes.
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Support Quality and Validation activities for product transfers and new product introductions.
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Responsible for ensuring conformance with current equipment, process, and systems validation regulations.
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Determine the implications of validations upon; Product Quality, Patient Safety, and Data Integrity.
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Assess effectiveness of measurement tools, destructive tests, non-destructive tests (measurement system analysis)
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Determine process inputs and factors for variation where process capability is required
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Responsible for reviewing Installation, Operating and Performance Qualification (IQ,OQ, PQ)s
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Partner with other cross functional partners to ensure the correct application of design controls, risk management and the investigation/correction of design failures/challenges.
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Conduct investigation, bounding, documentation, review and approval of non-conformances and CAPAs related to Materials projects. Escalation of quality issues as appropriate.
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Support root cause analysis activities related to material processes.
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Communicate effectively with internal team on actions and deliverables.
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Provide timely and accurate reporting and management of escalations as appropriate on project activities.
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Ensure all activities comply with GMP, ISO and quality system requirements
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Ensure that all health, safety and environmental requirements are fulfilled.
EDUCATION & EXPERIENCE REQUIREMENTS:
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Experience working in both an FDA and European regulatory environment is preferred.
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A thorough understanding of GMP regulations.
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Lean manufacturing experience is essencial.
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Strong verbal and written communication skills
- Extrusion and Injection Moulding experience is preferrable.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
