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Sr. Supplier Quality Development Engineer (2…
- J&J Family of Companies (Santa Clara, CA)
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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 6years 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.
+ Proactive, self-motivated, and able to work independently with minimal direction in a fast-paced environment while leading multiple priorities.
Preferred:
+ Strong technical understanding of manufacturing equipment and processes
+ Experience in medical devices, surgical robotics, or similarly regulated environments.
+ Technical exposure to machining and/or electromechanical manufacturing processes.
+ Auditing experience or formal auditor training.
+ Understanding of new product or process introduction
+ Experience implementing appropriate risk mitigation techniques.
+ Certifications such as CQE, CQA, Six Sigma, Lead Auditor, or PMP.
+ Proficiency with GD&T and its impact on inspection planning and MSA.
Other:
+ Ability to lift items up to 25 lbs.
+ Ability to travel domestically and internationally up to 30%.
Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
\#LI-Onsite
Required Skills:
Preferred Skills:
Coaching, Communication, Compliance Management, Controls Compliance, Cross-Functional Collaboration, Data Compilation, Econometric Models, ISO 9001, Issue Escalation, Performance Measurement, Problem Solving, Quality Control (QC), Quality Standards, Standard Operating Procedure (SOP), Technologically Savvy, Vendor Selection
The anticipated base pay range for this position is :
$109,000.00 - $174,800.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
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