Sr. Supplier Quality Development Engineer (2 openings)

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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 were 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 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 were 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 & Johnsons 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:

• Bachelors 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.

• 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 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 :

$109000.00 - $174800.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).



This position is eligible to participate in the Companys 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: - Experience:

Senior IC