Johnson & Johnson Careers
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Director New Product Introduction, Quality Engineering
Requisition ID: 8611180510
Johnson & Johnson Vision is currently recruiting for a Director New Product Introduction, Quality Engineering to be located in Jacksonville, FL.
Johnson & Johnson Vision is committed to improving and restoring sight for patients worldwide. Since debuting the world’s first disposable soft contact lens in 1987, it has been helping patients see better through their world-leading ACUVUE® Brand Contact Lenses. In 2017, J&J expanded into cataract surgery, laser refractive surgery (LASIK) and consumer eye health and now serves more than 60 million patients a day across 103 countries with its eye health portfolio. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
In this role you will plan and Lead multiple new product introduction projects across various platforms through the New Product Introduction process. Provide consulting, training and guidance on statistics, quality systems and the Development and Transfer activities throughout the company. Lead teams for developing training, quality systems and validation programs. Performs other related duties as assigned by management.
- Manages the R&D Quality Engineering (QE) function and quality systems within Research & Development and Value Streams as it relates to new product introductions (NPI) in compliance with current quality systems for CTQ flow-down, design control, validation and risk management. This position has NPI QE responsibility for J&J Vision.
- Own NPI validation procedure, strategy and testing.
- Manage the performance of assigned staff ensuring the organization’s product meets all government regulations and company quality standards.
- Ensures that company's quality system programs, procedures and practices are compliant with J&J corporate and applicable government medical device regulations including FDA QSR, and ISO 13485.
- Ensures the Voice of Customer is appropriately captured for best-in-class performance of new products against predicate devices, competitors and market expectations.
- Define and Monitor Quality Program for effectiveness, communicate quality performance, and drive Quality Improvement Initiatives.
- Evaluate impact of internal and external quality non-conformances in the new product introduction space.
- Provide quality consultation to internal and external customers in support of organizational objectives.
- This position also provides technical leadership and establishes appropriate systems to ensure departmental compliance with regulatory requirements.
- Represents functions at internal and external functions as needed to support regulatory compliance.
- Defines complex issues; recommends and guides implementation of functional strategies; leads departmental/projects day-to-day operations within area of responsibility. Spokesperson for functional area. Technical expert for functional area; makes the complex clear and compelling; conceptual knowledge of all responsible functions and business areas. Represents the department/project in providing solutions to difficult technical issues.
- Resolves and manages technical and tactical operational problems. Establishes key operating practices for department/project and functional area, ensuring cross-functional synergy. Drives innovation within functional area.
- Mentors and facilitates successful team behavior within and across functional area and typically serves in a project leadership role. Manages relationships externally and internally for functional area. Builds cross-functional and cross-departmental support. Fosters overall group effectiveness.
- Holds people accountable for measurable results. Provides coaching, useful feedback, and direction to direct reports/teams. Ensures and measure improvement for development of staff. Identifies high potential candidates. Fosters harmony within functional and other areas. Promotes the business value of diverse perspectives. Influences and persuades to bring about process and technical improvements.
- Adheres to environmental and safety policies and procedures and supports department’s safety and environmental objectives.
- Bachelor Degree - Science/Engineering related field
- A minimum of10 year industry experience working in R&D, Quality Assurance/Regulatory Affairs.
- A minimum of 5 years managerial experience or advanced management training.
- Thorough knowledge of FDA and International Regulatory requirements.
- Excellent organizational, interpersonal, written and oral communication skills required.
- Medical Optics experience is a plus.
- Manufacturing experience is preferred.
- Position based in Jacksonville, FL. Travel requirement: 25% with some months at 50%.
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.
Johnson & Johnson Vision Care, Inc. (6094)