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

JOB DESCRIPTION:

Johnson and Johnson Vision, (a member of Johnson & Johnson Family of Companies), is recruiting for a Senior Engineer, External Manufacturing & Supplier Quality. The preferred location is Irvine, CA. However, the role can also be located in Milpitas, CA.
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/.
The Senior Engineer, External Manufacturing and Supplier Quality provides strategic and tactical support to External Manufacturing by executing quality activities such as: base business support and nonconformance root cause investigation in order to maintain and improve customer satisfaction, eliminate errors and improve efficiency. The individual is responsible to build business partnerships with suppliers and internal stakeholders / technical experts (i.e. Procurement, Operations, R&D, Supply Chain, NPI) to eliminate supply chain risks, while implementing continuous and innovative improvements with demonstrated and measurable results.

EDUCATION:

• A minimum of a Bachelor’s or equivalent University degree is required; a concentration in Engineering or related scientific field is preferred.

• Provide sound, risk-based QA direction and independent and timely decision-making on a wide range of quality and compliance issues. Includes working with suppliers and internal resources to perform root cause analysis/failure investigations, identifying and approving of supplier corrective actions, and monitoring supplier’s implementation / effectiveness. Provides oversight and escalation for product related issues.
• Ensure compliant execution of Quality Management Systems including but not limited to EM: selection, change control, qualification, approved supplier list, NC/CAPA, Quality agreements and performance monitoring.
• Provide leadership across activities associated with supplier risk identification & management, including planning and execution of supplier risk & control plan assessments and the ownership and creation of Quality Agreements.
• Exercise strong communication and interpersonal skills, with the ability to work independently and in a team environment, to effectively support supplier relationship
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements under limited supervision
• Adaptable and flexible for other duties that may be assigned as needed