Johnson & Johnson · 3 hours ago
Supplier Quality Development Engineer
Cincinnati, Ohio, United States of America
Full-time
Hybrid
Entry, Mid Level
$65K/yr - $105K/yr
2+ years expJohnson & Johnson is a leader in healthcare innovation, focused on developing smarter and less invasive treatments. They are seeking a Supplier Quality Development Engineer to drive supplier readiness and quality for complex components essential to their surgical robotics systems, collaborating with various teams throughout the development and qualification processes.
Hospital & Health Care
Responsibilities
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 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
Qualification
Required
Bachelor's 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
Benefits
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
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
Company
Johnson & Johnson
At Johnson & Johnson, we believe health is everything.
10001+ employees
H1B Sponsorship
Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (48)
2024 (56)
2023 (58)
2022 (59)
2021 (44)
2020 (27)
Funding
Current Stage
Late StageLeadership Team
Alex Gorsky
Former Chairman and CEO, Johnson & Johnson
Joaquin Duato
Chairman of the Board and Chief Executive Officer
Recent News
2025-10-07
2025-10-07
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