Supplier Quality Development Engineer

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:

Supply Chain Engineering

Job Sub Function:

Mechanical Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Cincinnati Ohio 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 Supplier Quality Development Engineering located in Cincinnati OH.

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 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. TheSupplier Quality Development Engineerwill 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.

• Managing purchase 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 CTQs 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:

• Bachelors degree in Engineering or related technical field.

• Minimum 2 years of 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 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.

• 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:

Analytical Reasoning Auto-CAD Design Design Thinking Execution Focus Industrial Hygiene Issue Escalation Lean Supply Chain Management Mechanical Engineering Problem Solving Product Reliability Project Engineering Project Management Project Management Methodology (PMM) Quality Control (QC) Regulatory Compliance Safety-Oriented Science Technology Engineering and Math (STEM) Application Technical Credibility Technologically Savvy

The anticipated base pay range for this position is :

$65000.00 - $104650.00

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:

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