Johnson & Johnson Careers
Senior Quality Manager, Value Stream
Anasco, Puerto Rico
Requisition ID: 2094180523
Johnson & Johnson Vision, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Quality Manager, Value Stream.
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.
As the Senior Quality Manager, Value Stream, you will:
• Plan, direct, and conduct projects of major scope and significance to the Company with full technical responsibility for interpreting, organizing, executing and coordinating resource allocation, assignments and timely project delivery.
• You may contribute inventions, new designs or techniques which are significant in the solution of important problems.
• Support processes in the Base Business and supervise, lead and mentor other professionals and Engineers, advice top management on technical matters and will utilize Quality Engineering tools and methods for the effective and efficient development, transfer, and maintain products/processes throughout the product lifecycle.
• Supervise the personnel, deployment and execution of Quality Systems within the primary areas of responsibility to ensure compliance and to support the effectiveness and efficiency of the manufacturing process. This includes, ensuring all direct personnel are properly trained to perform their assigned functions in accordance with applicable Work Instructions (WI).
• Serve as Quality Subject Matter Expert for assigned areas and work with multi-functional teams to establish operational plans to ensure uninterrupted support to manufacturing operations.
• Serve as a consultant in the Quality related operations and Quality Systems applicable to the plant products and processes, as well as, provide support on activities, documents and records requiring Quality Engineering review or approval as deemed necessary.
• Lead or aid the execution of validation and verification activities associated with process, equipment, computer system validation, laboratories and test methods.
• Write process, test method, equipment, cleaning and computer based validation protocols and reports.
• Conduct or participate in troubleshooting and deviation investigation efforts including Non-Conformances, Corrective and Preventive Actions (CAPA), and complaints.
• Execute Six Sigma/Process Excellence projects to characterize and optimize procedures, equipment or processes.
• Create and review documents, Standard Operating Procedures (SOP), practices and new approaches.
• Identify, prioritize, and execute quality and cost improvement projects that support business goals by using engineering principles, tools, and practices.
• A minimum of a bachelor’s degree is required, preferably in Engineering.
• Professional Engineer/Engineer in Training License is preferred.
• Computer System Validation or Automation certification is preferred.
• A minimum of eight (8) years of experience in Engineering or Quality Assurance management functions is required.
• Experience in the Pharmaceutical or Medical Device industry is required.
• Experience with Computer System Validation (CSV) and validation of new products and processes are required.
• Experience managing and hosting of regulatory bodies and agencies is required.
• People management experience is required.
• Proficiency in English and Spanish (oral and written) is required.
• Proficiency with Microsoft Office tools (Word, Excel and PowerPoint) is required.
• This position requires up to ten percent (10%) of travel.
• Ability to work extra hours and weekends as per operational needs is required.
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.
United States-Puerto Rico-Anasco
AMO Puerto Rico Manufacturing, Inc. (Branch) (7239)