J&J Family of Companies Staff Quality Engineer in Irving, Texas
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.
The Staff Quality Engineer will use 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.
• Provide strong leadership in the 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
• 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.
• Analyzes 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.
• Will supervise technicians in the execution of product control for nonconforming product to identify, segregate and disposition product through the Nonconforming System.
• Bachelor’s degree (B.S.) in engineering, science, mathematics or statics required.
• A minimum of 4 years related manufacturing experience is required; or equivalent combination of education and experience is desired. Experience in the medical device, pharmaceutical or other highly regulated industry is required.
• Knowledge of ISO and/or cGMP regulations is preferred. Experience in a FDA regulated environment is an asset.
• An ASQ certification (CQE, CQM, CRE or CQA) is an asset. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset.
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc. The ability to perform "hands on" troubleshooting and problem solving is required. Good technical understanding of manufacturing equipment and processes is required.
• Demonstrated project management and project leadership abilities are required.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
Mentor Texas LP (6182)