Johnson & Johnson Careers
Senior Supplier Quality Engineer
Requisition ID: 6281190604
Johnson & Johnson Surgical Vision (JJSV) is recruiting for a Senior Supplier Quality Engineer to be located in Milpitas, CA. JJSV Milpitas designs, manufactures, and distributes equipment products for Refractive and Cataract surgery.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We value research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in healthcare to touch the lives of over a billion people every day, throughout the world.
JJSV's goal is improving sight throughout a patient’s lifetime. J&J Surgical Vision is well positioned to address a full range of vision health needs for global markets: The No. 2 global provider of CATARACT products and a leader in presbyopia-correcting IOLs, the Global REFRACTIVE (LASIK) market leader, all supported with a CONSUMER EYE HEALTH diverse portfolio of solutions and drops.
JJSV has operations in the United States, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Our associates around the world are committed to expanding our brands and fortifying our position as the worldwide leader in the industry.
As key member of our Supplier Quality Organization, you will provide overall quality assurance leadership and serve as supplier-related technical and quality lead for pre-market and on-market product by ensuring the outsourced activity and product is qualified for use by the business unit.
Key areas of focus within supplier management are leading supplier & process qualifications, leading issue/defect resolution, managing & reporting on supplier performance, ensuring compliance to J&J standards, process improvement, and supporting supplier, internal & external audits.
Your contributions will include providing direction to suppliers and project teams on: mistake proofing, validation, risk management, change control, problem solving, statistical process control, and process improvement.
Your main areas of responsibility will include:
• Actively participate on team projects in a structured business environment aligned with internal company policies, procedures and applicable regulatory requirements.
• Lead meetings with suppliers and external manufacturers (EM) to ensure communication and alignment of objectives.
• Support internal and/or external and cross sector project teams to driving supplier/EM improvement such as: reducing variation in supply chain, establishing robust processes, instituting control plans, and improving process capability.
• Lead supplier root cause investigations and corrective actions from a variety of sources including incoming inspection, manufacturing, field service and complaints.
• Monitor and report supplier and internal performance & quality metrics and support product/process improvements.
• Support new product development by ensuring suitability of internally-developed specifications, instructions and test methods and leading the design transfer to the supplier, including providing QA technical and compliance expertise for risk analysis/assessments and process/test method validations.
• Participate in decisions regarding work processes, plans and schedules in order to achieve department objectives.
• Track and report progress across projects by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans.
• Facilitate supplier quality system audits and associated actions.
• Provide internal and third-party inspection support. Accountable for compliance with regulations including FDA 21 CFR 820, ISO 13485, EU MD Directive/Regulations, Japan PAL, Canada CMDCAS, Brazilian ANVISA, and Australian TGA for assigned products.
• A minimum of a Bachelor's Degree is required
• Preferred majors are Electrical, Mechanical or Industrial Engineering or related science/technical field or an equivalent.
• 4 plus years experience in an FDA regulated industry (Biotech, Pharma or Medical Device manufacturing) is required.
• Basic understanding of the Medical Device Quality Systems is strongly preferred.
• Strong computer skills such as Word, Excel, PowerPoint, Visio, & MS Project highly preferred.
• Strong written and verbal communication skills is required
• Experience in the Medical Device industry is preferred. Experience with Electrical, Mechanical, Chemical, Packaging, Plastics or other manufacturing industries is preferred.
• Basic understanding of FDA and ISO regulations is preferred. Experience with 21 CFR 820; 21 CFR 210/211; ISO 13485; ISO 9001; Canadian CMDCAS; Japanese PAL; Brazil ANVISA, Australian TGA, and EU MDR is preferred.
• Ability to travel up to 30% travel required
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.
AMO Manufacturing USA, LLC (6240)