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Staff Quality Engineer- Mentor
Requisition ID: 0504180119
Mentor Worldwide L.L.C., a member of the Johnson & Johnson family of companies, is recruiting for a Staff Quality Engineer for its location in Irving, TX.
Mentor Worldwide L.L.C is a trusted global leader in aesthetic medicine among both consumers and clinicians by providing a broad range of innovative, science and clinical-based solutions to maintain, enhance, and restore self-esteem and quality of life. The company has products and services in three areas of aesthetics: breast (augmentation and reconstruction), body and face.
You the Staff Quality Engineer will use Quality Engineering principles, tools and techniques to develop, and optimize, and support systems and processes that are aligned with the overall Company strategy and mission affecting continuous quality improvement.
- Lead Quality Operations department to ensure all quality objectives and goals are met and help develop and drive strategic direction of the organization in the areas of quality operations and compliance.
- Capable of the developing junior quality engineers and quality technicians in the use of Process Excellence tools and Quality Systems to make data driven, risk based decisions that ensure the quality of the product.
- Support, consult, train and lead quality improvement projects throughout the life cycle of Mentor products, including product design and development, and manufacturing.
- 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.
- Analyses routine and test data looking for improvement opportunities. Designs and implements experiments (DOE's) for process and product improvement and validation testing.
- Provides statistical support for sampling plan analysis, DOEs, Paretos, ANOVA, and SPC applications, and other statistical applications as required.
- Evaluate manufacturing quality performance capability and develop criteria to monitor and improve existing processes.
- Serves as technical review for validation activities, i.e. protocols and reports.
- Investigate nonconforming material and the determination of cause, corrective action and recommendation of 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 upon the facility quality objectives, reporting monthly on progress made against those goals. Prioritizes work to achieve deadlines.
- Comprehension of the quality System Regulation (21 CFR PART 820), ISO 13485 requirements, MDD and Canadian Regulation.
- Serves as the Quality Engineering expert on assigned responsibility areas and has conceptual understanding of all Quality functions and business areas.
- Perform Internal Audits to ensure compliance with QSR, ISO 13485, MDD and Canadian Regulation in accordance with the Internal Audit schedule.
- Bachelor’s degree (B.S.) in engineering, science, mathematics or statistics is required. Master’s degree in engineering science or mathematics is preferred.
- A minimum of 6 years of related work experience is required. Medical device manufacturing experience is highly desired. Experience in highly regulated industry is required.
- Good technical understanding of manufacturing equipment and processes is required.
- Demonstrated influential, leadership skills, and able to work on cross-functional teams are required. Six Sigma Blackbelt or Greenbelt certifications are preferred.
- Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and can present data that facilitates/drives decision making is required.
- Knowledge of Good Manufacturing Practices (GMPs) and ISO policy and procedures is preferred.
- Demonstrated project management skills, such as supporting multiple projects simultaneously are required.
- A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
- This position will be located in Irving, TX and will have up to 10% travel both domestic and international.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Mentor Texas LP (6182)