Associate Supplier Quality Development Engineer

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

R&D Product Development

Job Sub Function:

Biomedical Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Cincinnati, Ohio, United States of America

Job Description:

There is a candidate pre identified.

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 Supplier Quality Development Engineering, located in Cincinnati, OH.

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 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. The Supplier Quality Development Engineer will partner with the Research & Development, Product Management and Advanced Sourcing & Innovation teams throughout both the development & qualification processes of components to final product.

As the Supplier Quality Development Engineer your responsibilities include:

• Component development as part of New Product or Process Introduction process.

• Support supplier selection & oversight for highly engineered components.

• Support purchasing controls for qualified supplier and managing new supplier qualifications (which includes audits, regulatory and compliance reviews, managing quality agreements and assessing supplier classifications)

• Leading and/or contributing to implementation of Critical to Quality requirements for externally manufactured components ensuring robust processes at suppliers that meet CTQ’s for Finished Products and Direct Materials

• Qualification of highly engineered components, assemblies, special processes, and finished products including but not limited to PFD, pFMEA, FIAs, Control Plans, GRR, and Process Validation.

• Demonstrating strong proficiency in applying established tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions, as well as process and business improvements.

• Utilizing statistical analysis tools for data driven decision-making.

• Leading supplier change notification review with cross functional teams

• Act as technical liaison between R&D, Procurement, Development and Supplier.

• Conducting and supporting the development of test methods in equipment, process, and product qualifications/validations.

• Leading and/or contributing to test method validation (TMV) and measurement system analysis (MSA), and development of inspection strategies. Practical application of differentiation of test methods utilized (i.e. CMM vs. vision methods) for appropriate tolerances and manufacturing methods.

• Leading and/or contributing to the utilization of various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode and effects analysis, risk assessment).

• Leading and/or contributing to supplier nonconformance investigations, working directly with suppliers to lead root cause analysis and implement effective corrective and preventive actions.

• Developing, implementing, and/or maintaining process control plans that are in accordance with product or process risk levels.

• Developing, implementing, and/or maintaining production and process controls using appropriate techniques and tools (for example, advanced process monitoring and control tools, methods of statistical process control, process performance metrics).

• Interpreting standard and non-standard sampling plans.

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

Experience and Skills:

Required:

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

• 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:

• Prior industry or co-op related experience in supplier quality, manufacturing, or quality engineering roles.

• Experience with 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 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.

• Geometrical Dimensioning and Tolerancing (GD&T) experience with an understanding of ASME Y14.5.

Up to 30% travel may be required.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

$64,000.00 - $102,350.00

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)).
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
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