Sr. Supplier Quality Development Engineer (2 openings)

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 Function:

Quality

Job Sub Function:

Supplier Quality

Job Category:

Professional

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for Sr. Supplier Quality Development Engineer (2 openings), located in Santa Clara, CA.

At Johnson & Johnson Robotics & Digital Solutions, we’re building the future of surgery. Our OTTAVA™ robotic platform unites advanced engineering, digital technologies, and precision manufacturing to deliver next-generation solutions that transform patient care.

We are seeking a Sr. Supplier Quality Development Engineer to join our rapidly growing team. This is a high-impact, cross-functional role driving supplier readiness and quality for a range of complex components — from precision-machined parts to electromechanical assemblies — that are essential to the performance and safety of our surgical robotics system.

Key Responsibilities

• Lead supplier onboarding activities: including selection, risk assessment, quality agreements, supplier audits, and supplier system setup across Johnson & Johnson’s enterprise platforms.

• Collaborate across sourcing, engineering, and operations to develop supplier capabilities aligned with program requirements and timelines.

• Conduct or facilitate supplier quality audits and support quality system gap closure and development planning.

• Drive nonconformance investigations, working directly with suppliers to lead root cause analysis and implement effective corrective and preventive actions.

• Monitor supplier performance data, conduct trend analysis, and find opportunities for continuous improvement or risk mitigation.

• Lead Supplier Change Notification (SCN) reviews, ensuring proper risk assessment, cross-functional alignment, and implementation controls.

• Initiate and manage Supplier Corrective Action Requests (SCARs) and track timely, robust resolution.

• Own and facilitate part qualification activities (PQP), including requirement review, risk management, Process Flow Diagrams, pFMEA, First Article Inspections, GR&R, Control Plans, Capability Studies, Inspection Planning, and Process Validation.

• Support internal and external audits (e.g., FDA, Notified Body) and represent supplier quality elements as needed.

• Participate in decisions that are aligned with management objectives regarding work processes, plans, and schedules to achieve department objectives.

• Tracks and report progress across projects and department commitments by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans.

• Monitors compliance with company policies, procedures, and applicable regulatory requirements.

Experience and Skills:

Required:

• Bachelor’s degree in Engineering or related technical field.

• Minimum 6 years of experience in supplier quality, manufacturing, or quality engineering roles.

• Proficient in root cause analysis, CAPA, and part qualification tools (e.g., pFMEA, GR&R, control plans, process validation).

• Familiarity with FDA QSR (21 CFR Part 820), ISO 13485, and regulated industry expectations.

• Strong problem-solving,  data analysis and technical writing skills; solid understanding of capability studies, trending, and statistical tools.

• Excellent communication and leadership skills across technical and business functions.

• Fast learner, comfortable navigating complex IT systems, documentation platforms, and enterprise quality systems.