Key responsibilities of a Senior Quality Engineer:
• To actively lead or participate in product complaint investigations applying a Process Excellence approach using quality tools such as FMEAs, Hazard Analysis, Process Flow Maps, and DOEs. Responsible for test protocol development, root cause analysis, and report writing.
• To ensure that conclusions from investigations 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 conclusions from investigations are appropriately supported by facts, that corrective and preventive actions address the root cause, and all aspects of the investigations are thoroughly documented.
• To recommend changes to products or specifications, as required, to improve quality performance.
• To establish and track appropriate measures of quality for field complaints and defects and communicating these to management. Ensure that indicators with poor outcomes are addressed through an appropriate action plan.
• To participate in New Product Introductions as required in the Development process and ensure appropriate design transfer into Manufacturing.
• 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 Cardiac Science business objectives.
• To ensure that assigned CAPA records are progressing within timelines. Provide guidance, as appropriate, to CAPA owners and ensure that conclusions from CAPA investigations are supported by facts and all aspects of the CAPA are thoroughly documented.
• Interface with Supplier Quality Engineers to drive improvements relating to component quality.
Essential Requirements
• The employee must have a B.S. Degree in Science or Engineering
• Minimally, 3 - 5 years experience in an FDA regulated medical device or IVD manufacturing company.
• A thorough understanding of US FDA QSRs and ISO 13485
• Thorough understanding of quality improvement tools such as Six Sigma and Lean Manufacturing.
• Strong knowledge of statistical methods, including statistical process control and sampling techniques.
• Demonstrated failure analysis experience working across functional groups to determine root cause.
• Must be a self starter and able to manage a variety of tasks simultaneously with minimal day-to-day supervision.
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