Key responsibilities of a Process Quality Engineer:
• To ensure that AED manufacturing in Deerfield and Malaysia are in compliance with US FDA QSRs and international regulatory requirements and ISO 13485:2003 standards requirements.
• To disposition nonconformances generated by AED maunufcaturing in Deerfield and assure adequate and timely corrective and, when applicable, preventive actions.
• To lead or participate in AED-related Product and/or Process Failure Investigations in Deerfield and Malaysia applying, where possible, a Process Excellence approach using quality tools such as FMEAs, Hazard Analysis, Process Flow Maps, and Design of Experiments.
• To ensure that conclusions from AED-related investigations done either in Deerfield or in Malaysia are appropriately supported by facts, that corrective and preventive actions address the root cause, and all aspects of the investigations are thoroughly documented.
• To ensure that internal & external audit findings related to AED manufacturing in Deerfield or in Malaysia are addressed.
• To ensure all validations required to support AED manufacturing are current and meet current requirements. Provide advice on validation requirements and review validation documentation.
• To establish appropriate measure of quality for AED manufacturing in Deerfield and Malaysia and communicating these to management. Ensure that indicators with poor outcomes are addressed through an appropriate action plan.
• To identify and lead or participate in opportunities to continuously improve, using appropriate Process Excellence and Lean Manufacturing tools, quality, cost and time factors consistent with the business objectives.
• To ensure that CAPA records assigned to any aspect of AED manufacturing whether here or in Malaysia are progressing within timelines. Provide guidance, as appropriate, to CAPA owners and ensure that conclusions from investigations are supported by facts, that corrective and preventive actions address the root cause, and all aspects of the CAPA are thoroughly documented.
• To identify and train others within AED manufacturing to ensure thorough understanding of Compliance.
• Interface with Supplier Quality Engineers to drive improvements relating to component quality.
Qualifications:
• The candidate must have a B.S. Degree in Science or Engineering
• A thorough understanding of US FDA QSRs and ISO 13485
• Minimally, 5 years experience in an FDA Class II regulated medical device or IVD manufacturing company or +3 years experience with Class III devices.
