Senior Quality Engineer

J&J Family of Companies • Plymouth, MN • 18h ago

At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and less invasive, and?solutions are personal.?Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.?Learn more at https://www.jnj.com

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Plymouth, Minnesota, United States of America

Job Description:

Employer: SterilMed, Inc

Job Title: Senior Quality Engineer

Job Code: A011.7755

Job Location: Plymouth, MN

Job Type: Full-Time

Job Duties: Develop measurement systems to monitor the effectiveness of QA and reliability systems to identify, bracket, correct, and prevent defects, demonstrating continuous improvement to management. Provide support and expertise in the implementation and enforcement of GMP, ISO, and FDA requirements, and maintain alertness to changes in the industry and regulatory environments, applying this information to business practices. Prepare QA systems and assist in technical issues for manufacturing processes that are to be transferred to satellite facilities. Manage established processes in support of steady-state manufacturing in accordance with the defined QA program for product transfers. Provide statistical support and expertise in DOE (Design of Experiments) and analytical problem solving for manufacturing, technical services, and product development to minimize sample and scrap waste, assess reliability and risks based on data presented, identify root causes of problems, and reduce and identify sources of variation. Audit and approve manufacturing, quality, engineering, and validation/qualification documents for conformance to company business practices and departmental procedures. Support the development of validation strategies and act as a liaison to the Regulatory Affairs department to perform initial regulatory reviews of all engineering changes/modifications to products. Perform analysis of documents and information to ensure that all critical product characteristics have been identified and properly evaluated, including design specifications, FMEA (Failure Mode Evaluation and Analysis) for product and process material specifications, QA system (in-line control points) - FGI results, product inquiry analysis, reliability analysis, and R&D Laboratory support. Provide sampling plans and approve inspection methods for evaluation and testing of components and products. Support the Continuous Release program, where applicable, to reduce the need for FGI inspection, and provide support and expertise in reliability strategy and reliability growth demonstration during new product development.

Requirements: Employer will accept a Master's degree in Biomedical Engineering, Systems Engineering, Quality Engineering Management, Business Management, or related field, and three years of experience in job offered or in a Senior Quality Engineer -related occupation.

This job posting is anticipated to close on 8/11/2025.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

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