Staff Quality Engineer New Product Introduction Lifecycle Management NPI LCM Job
Johnson & Johnson
Job Code - 52481
Position - See job description
Job First Active on: Monday, February 27, 2012
Staff Quality Engineer, New Product Introduction Lifecycle Management (NPI LCM)
Mentor Worldwide L.L.C., which joined Johnson & Johnson in 2009, is recruiting for a Staff Quality Engineer, New Product Introduction & Lifecycle Management located in either Santa Barbara, CA or Somerville, NJ or Irving, TX.
Mentor 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 be responsible for leading the Quality Engineering efforts for New Product Introduction and Lifecycle Management by utilizing Quality Engineering tools for the effective and efficient development, transfer, and maintenance for products and processes throughout the product lifecycle. This position will be responsible for utilizing quality engineering principles and problem solving skills to develop and optimize products and processes that are aligned with the overall Quality and Business vision for the Plastic Surgery Channel of Johnson & Johnson related to breast, body contouring, and dermal fillers.
This position will be responsible for the Quality Engineering efforts including but not be limited to implantable class III products, pre-market approvals (PMAs), 510Ks, effective risk management, and Product Quality Plans.
The Staff Quality Engineer will function as a project team lead in matters related to Quality Engineering and effective and efficient use of Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, statistical process control, and the development of sample plans. This position will develop a comprehensive risk management plan for the products and processes, and ensure the delivery and utilization of effective quality strategies for validation, while ensuring the development of appropriate test methods for product and process performance. This role will be responsible for the effective and consistent application of Quality Engineering, PE tools and techniques, including active and thorough investigation of quality issues and effective corrective and/or preventive action. The Staff Quality Engineer will effectively utilize Process Excellence to solve problems and develop optimal products and processes to ensure compliance with company policies and procedures as well as provide guidance and recommendations involving the implementation of regulatory requirements (e.g., Quality System Regulation, EU MDD, ISO standards, etc.).
Additionally, the Staff Quality Engineer will partner with Research & Development on New Product Introduction, to ensure the application of design controls and product risk management as well as the investigation/correction of design failures/challenges and effective design control and transfer. In collaboration with Research & Development the Staff Quality Engineer will also assist with new test method development and validation and proactively communicate with Manufacturing Quality Engineering/Supplier Quality Engineering product CTQs for process development/validation/control.
This position will also be responsible for partnering with Engineering and Suppliers to ensure the application of process validation, process control, and process risk management, are in compliance, as well as complete and assure the accurateness of investigations and corrections of process failures. The Staff Quality Engineer will implement and monitor process capability for continuous improvement, effective change control, and be responsible for proactively communicating with Design Quality Engineering any changes in the product design or product changes that could affect the product design. The Staff Quality Engineer will ensure supplier performance is monitored and addressed as needed, providing leading metrics to Quality Assurance and Regulatory Affairs Business Unit Directors.
The Staff Quality Engineer will also be responsible for Lifecycle Management Support. For this aspect, the successful candidate will partner with Operations Engineering in the application of process validation, process control and process risk management for investigating/correcting process failures. The Staff Quality Engineer will be responsible for implementing and monitoring process capability for continuous improvement, ensuring effective change control and proactively communicating with the Design Quality Engineering team, any changes in the design or changes in the process that could affect product design.
REQUIREMENTS - QUALIFICATIONS: Staff Quality Engineer, New Product Introduction Lifecycle Management (NPI LCM)
At minimum of a BA/BS degree (BS Engineering preferred) or equivalent in a Life Science, Engineering, or Physical Science is required. A minimum of 6 years relevant working experience is required for this position. PMA, 510k or equivalent experience is required, Pharmaceutical or BLA experience is an asset for this position. Medical Device experience is required. A minimum of Six Sigma Green Belt Certification is required for this opportunity, a Six Sigma Black Belt Certification is preferred and a Master Black Belt Certification is highly desired. An ASQ Certification is also a preference. Experience with New Product Introduction or Development is required. Experience collaborating with external suppliers preferred. Experience with Design Controls is required. Experience with product reliability or reliability engineering is required. Risk Management experience is required. Process Capability experience and Process Validation experience is required. A Demonstrated knowledge and application of industry regulations is required. QSR, MDD, ISO 13485, ISO 14971, cGMP, and other international standards preferred. Geometric Dimensioning and Tolerancing experience is required for this position. Data analysis (statistical analysis, sampling plans, Statistical Process Control, etc) experience is required. Prior CAPA experience is highly desired. Up to 30% domestic and international travel is required, potentially peaking over that amount at times, depending on the base location for the position. Prior experience leading teams and/or having direct reports is highly desired. Prior experience with statistical software is also required (Minitab, SAS, Statistica, etc). This position is based in either Santa Barbara, CA or Somerville, NJ or Irving, TX. BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
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