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.

Qualifications

Requirements: Employer will accept a Bachelor's degree in Industrial Engineering, Systems Engineering, or related field followed by 6 years of progressive, post-baccalaureate experience in the job offered or a Staff Lifecycle Quality Engineer-related occupation.

May telecommute.

This job posting is anticipated to close on 8/21/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company's long-term incentive program.

Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

Additional information can be found through the link below.

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]