Johnson & Johnson Surgical Vision, Inc., a member of the Johnson & Johnson Family of Companies, is recruiting for a Manager, External Manufacturing & Supplier Quality! This position will be located in Irvine, CA and requires travel to a critical EM partner in Tijuana, Mexico.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges. We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong.

Are you interested in joining a diverse team that is helping improve patient care and drive innovation? Apply today for our Manager opportunity!

The Manager, External Manufacturing & Supplier Quality is highly independent and accountable for providing overall operational quality assurance and compliance leadership in the management of suppliers and/or external manufacturers (EM). Will develop, establish, carry out and maintain strategies, programs, procedures and controls, ensuring that supplier and/or EM performance and the associated quality systems metrics are continually met to drive outstanding performance. This position aids in the identification and elimination of Supply Chain and Quality System risks via internal and supplier partnerships. The position will deliver distinctive value to the organization through the execution of manufacturing/technology transfers and new product launches. The incumbent will lead/participate in supplier/EM engagements to assess technical proficiency and general compliance to requirements, such as material specifications, critical to quality attributes, process control plans, quality agreements, etc. Focus areas are risk identification, non-conformance resolution, supplier reliability, performance monitoring/reporting, compliance to J&J standards and continuous process capability improvement.

Key Responsibilities:

• Perform quality processes including change control, non-conformance management/resolution, product and material qualifications, and execution of quality agreement responsibilities for suppliers/EMs.
• Lead effective defect resolution, root cause investigation and continuous improvement activities. Maintain, support compliance of and improve processes, including procedural and electronic systems.
• Represent the Supplier Quality function and Purchasing Controls within Health Authority and similar audits/inspections, as well as supporting third party inspections and audits at suppliers.
• Support internal and/or external multi-functional and cross sector project teams driving initiatives for reducing variations in supply chain, instituting control plans, and improving process capability.
• Collaborate with R&D and Supply Chain partners on the selection, evaluation, and approval of new suppliers, participating in select quality audits.
• Apply Quality Engineering tools such as Failure Mode & Effects Analysis (FMEA), Fault Tree Analysis (FTA), Root Cause Analysis, Design of Experiment (DOE), etc. to the development of new products or processes related to raw materials, services and finished products.
• Provide Quality Engineering support and ensure compliance to JJV policies and HA regulations within process and product verification/validation activities.
• Participate in and influence during local site quality meetings, Management Reviews, Supplier Performance Reviews and similar to ensure communication and alignment of quality risks, supplier performance trends, and key projects/initiatives.
• Accountable for compliance in accordance with regulations such as and from, but not limited to, FDA 21CFR820, ISO 13485, EU MDD/MDR, Japanese MHLW, Health Canada, Brazilian ANVISA, Australian TGA for medical devices.
• Mentors and facilitates successful team behavior within and across functional area. Serve as back-up to Senior Manager EM & Supplier Quality (or Supervisor), leading development and execution of department strategies.
• Support alignment with enterprise standards, provide regulatory guidance and complete gap assessments in close collaboration with internal and external partners.
• Provide direction and/or supervision to contractor(s) as assigned.

Qualifications

Education:

University/Bachelor's or equivalent degree is required; a focus in Scientific, Technical, or Engineering field is preferred.

Experience and Skills:

Required:

• Minimum of eight (8) years of relevant work experience
• Detailed understanding and knowledge of the Medical Device Quality Systems and applicable Regulations (FDA and ISO regulations 21 CFR 820 and ISO 13485), with an emphasis on manufacturing and purchasing controls
• Proficiency with Microsoft Office (Word, Power Point, Excel) and functions for data analysis and trending
• Black/Green Belt certification or advanced working knowledge of Process Excellence/Lean Manufacturing/Six Sigma principles and practices, as well as experienced in their application

Preferred:

• Medical Device, Pharmaceutical, Chemical, Packaging, Electronics, or Plastics industry experience
• Solid understanding of EUMDD/EUMDR, ISO 9001, Canadian CMDCAS, Japanese MHLW, Brazil Anvisa, and/or Australian TGA
• Quality Engineer certification
• Ophthalmic Surgical Medical Devices experience
• Experience leading or supporting Manufacturing and/or Technology Transfers to EMs
• Experience leading or supporting New Product Introductions and/or technical transfers at EMs
• Experience leading high complexity projects
• Bilingual in English and Spanish

Other:

• Requires up to 30% travel, with periods of up to 50% travel based on business needs, domestic and international