Staff Lifecycle Quality Engineer

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Employer: Ethicon Endo-Surgery, Inc.

Job Title: Staff Lifecycle Quality Engineer

Job Code: A011.151

Job Location: New Brunswick, NJ

Job Type: Full-Time

Rate of Pay:$128,000 - $140,000

Job Duties: Use Quality Engineering tools and practices for the effective and efficient transfer and maintenance of products/processes throughout the product lifecycle, ensuring that the design integrity of surgical devices (electrosurgical instruments, surgical staplers, skin staplers, clip appliers, trocars) is maintained, and that devices and processes continue to meet user needs. Utilize Quality Engineering principles and problem-solving skills to improve and maintain devices and processes that are aligned with the overall Quality and Business vision. Implement appropriate risk management to prevent or mitigate unanticipated failure modes and improve process capability. Lead product lifecycle quality engineering, compliance, and systems initiatives for surgical medical device research, development, and design, specializing in laparoscopic surgeries and surgical staplers. Support execution of the change control process by providing subject matter expertise on devices and processes. Apply and ensure compliance with relevant regulations, standards, GxP requirements, and industry best practices. Identify and manage current and potential compliance and quality risks to prevent adverse effects to patients. Participate in new product or process transfer, business improvement, and lifecycle engineering. Lead and contribute to the usage of various Quality Engineering tools and practices, such as risk analysis and risk management, process validation, design validation, statistical data analysis, statistical process control, Failure Mode and Effects Analysis (Design, Process and Application). Provide input to design reviews, root cause investigations, and CAPA effectiveness assessment using various problem-solving techniques and tools including Six Sigma, 5 Why’s, and Ishikawa Diagram. Develop, implement, and maintain quality control plans in accordance with product or process risk level, and ensure plans are consistently followed. Develop, implement, and maintain production and process controls using appropriate techniques and tools, such as advanced process monitoring and control tools, methods of statistical process control, and process performance metrics, including statistical tools such as Control Charts, Scatter Diagrams, X-Bar and R Control Chart, Statistical Process Control (SPC), and process capability. Collaborate with Manufacturing Quality Engineering to ensure process-related failures are appropriately investigated, corrected / prevented, and escalated to management as needed. Monitor, chart, report on and recommend action on device-related customer product quality complaints.