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Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Irving, Texas, United States of America

Job Description:

Employer: Mentor Texas LP

Job Title: Sr. Quality OPS Engineer

Job Code: A011.8271

Job Location: Irving, TX

Job Type: Full-Time

Job Duties: Provide leadership in the Quality Operations department to ensure all quality objectives and goals are met and develop and drive the strategic direction of the organization in quality operations and compliance. Conduct failure investigations and collaborate with business partners to evaluate robust solutions to eliminate repeat quality-related issues. Review pending investigation reports for investigations awaiting quality assurance approval. Provide coaching and training to employees who generate investigations. Refer extraordinary situations to the quality assurance manager for final approval. Support the facility in identifying and eliminating compliance risks. Ensure that appropriate specifications and procedures pertaining to products are utilized. Ensure adherence to compliance requirements and policies outlined for marketing companies, external manufacturers, packaging and labeling, product testing, returned goods, product complaints, and recalls. Support, consult, train, and lead quality improvement projects to reduce defects and waste and increase reliability. Utilize Quality Engineering tools and techniques to establish sampling plans, develop quality plans, conduct and participate in FMEA activities, support reliability engineering activities, conduct process and systems audits, and support specification development. Analyze routine and test data to identify improvement opportunities. Provide statistical support for sampling plan analysis, DOEs, Pareto, ANOVA, SPC applications, and other statistical applications as required. Serve as a technical reviewer for validation activities, including protocols and reports. Investigate nonconforming material, determine the cause, recommend corrective actions, and recommend disposition for the Material Review Board. Apply research and benchmarking activities to create innovative solutions, validate their effectiveness, and facilitate their implementation. Develop personal performance objectives based on the facility’s quality objectives, report progress routinely, and prioritize work to meet deadlines. Ensure personal and company compliance with all Federal, State, local, and company regulations, policies, and procedures. Demonstrate an independent understanding and application of core GMP fundamentals, including Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs).

Requirements: Employer will accept a Bachelor's degree in Mechanical, Industrial, or Manufacturing Engineering, or related field and 3 years of experience in the job offered or in a Sr. Quality OPS Engineer-related occupation.

This job posting is anticipated to close on 6/24/2025. 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.

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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