Johnson & Johnson Careers
PRINCIPAL QUALITY ENGINEER NPI LCM
Irvine, California; Somerville, New Jersey; Irving, Texas; Somerville, New Jersey; Irving, Texas
Requisition ID: 6387190605
Mentor Worldwide LLC, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Principal Quality Engineer for New Product Introduction / Lifecycle Management, who can be located in either Irvine, California; Somerville, New Jersey; or Irving, Texas.
Mentor is a leading supplier of breast implants in the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow breast surgery patients to improve their quality of life. The company focuses on two strategic areas: breast reconstruction and breast augmentation. For over 20 years, more than 5 million women have chosen MENTOR® Breast Implants.
Mentor is looking for a strong quality engineer to play a key role in Quality and Compliance organization to act as project team leader or member in matters related to Product Quality, Risk Management and Compliance, to support business growth and compliance to industry standards and regulations.
Utilizes advanced Quality Engineering principles and problem-solving skills to develop, improve and maintain products/processes aligned with the overall Quality and Business vision. Utilizes appropriate risk management tools to prevent unanticipated failure modes and improve capability of processes.
• Ensures the development of a comprehensive risk management plan for the product and process. Partners with R&D to ensure the application of design controls and product risk management.
• Ensures effective quality strategies for validation, including the development and validation of appropriate test methods for product and process performance.
• Ensures active and thorough investigation of quality issues and effective corrective and/or preventive action, partnering with R&D, RA and Lifecycle Management teams.
• Effectively utilizes Process Excellence to solve problems and develop optimal products and processes.
• Supports Product Issue Assessment board leading investigations and presenting risk assessment outcome for decisions on field actions.
• Supports or leads resolution of health authority inquiries, partnering with cross function teams (including Post Market Surveillance, Complaint Handling Unit, Clinical and Medical Affairs and Medical Safety).
• Provides mentorship and recommendations involving the implementation of regulatory requirements (e.g., Quality System Regulation, EU MDR, ISO standards, etc.)
• Proactively communicate any changes in design or changes in process that could affect product design, ensuring effective change control.
• Develop systems to ensure quality of purchased raw materials and finished foods and participates on the development of CTQs and cascade to suppliers.
• Deliver Executive presentations to company's Board of Directors.
• Ensure compliance with company policies and procedures.
• Collaborates with Medical Safety and Post Market Surveillance on periodic monitoring of product performance and updates to risk management documents.
• Other duties and responsibilities as needed/assigned by the manger.
• A minimum of a Bachelor's Degree is required, preferably with a focus in a Life Science, Engineering, or Physical Science. Business degree or advanced technical degree is desirable.
• A minimum of 8 years of related experience is required.
• Experience with Class III Medical Device required
• Experience on New product development and design controls required
• Proven knowledge and application of QSR, MDD, ISO 13485, ISO 14971, cGMP, and other international standards.
• Computer Skills such as Word, Excel, Visio, & MS Project.
• Working knowledge of and experience in the application of statistical methods required, Minitab preferred
• Sense of urgency, intellectual curiosity, prudent risk-taking.
• Strong leadership as team leader, team member, leading others
• Strong working on global environments
• Ability to support 10-15% of global and domestic travel is required. Travel levels may differ based on home office (ie. Somerville, NJ; Irving, TX; or Irvine, CA).
• Green Belt or Black Belt certification from a recognized program
• Certified Quality Engineer (ASQ or equivalent)
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
North America-United States-New Jersey-Somerville, North America-United States-Texas-Irving, United States-New Jersey-Somerville, United States-Texas-Irving
Mentor Worldwide LLC (6177)