Senior Supplier Quality Dev Engineer
About The Position
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. The Senior Source Quality Development Engineer (Sr. SQE) leads source quality for Direct Material suppliers that make Johnson and Johnson Electrophysiology (EP) components, putting supplier quality strategies, standards, and processes into practice.
Requirements
- Bachelor's degree in engineering, applied science, or a related technical/quality field; mechanical or electrical engineering preferred.
- Minimum of 4 years' experience in Supplier Quality or Quality Engineering within the medical device industry.
- Demonstrated experience and ability to analyze and resolve complex issues using deductive reasoning, critical thinking, and a systematic problem‑solving approach.
- Working knowledge of regulatory compliance requirements (e.g., Quality System Regulations (QSRs), Medical Device Directive (MDD), ISO 9001, ISO 13485, ISO 14971, or other international standards).
- Ability to collaborate effectively with all levels of management and across cross‑functional teams.
- Broad experience with quality systems, including validation, nonconformance and CAPA systems, investigations, laboratory controls, and production/process controls.
- Experience in component qualification and process validation is strongly preferred.
- Broad knowledge of supplier quality management principles and Quality System Regulations.
- New product introduction (NPI) experience is desired.
Nice To Haves
- Six Sigma Black Belt or Green Belt (CSSBB/CSSGB), Lean certification from a recognized program, or PE leadership training preferred.
- Certified Quality Engineer (CQE) preferred.
- Flawless Project Execution (FPX) or Project Management Professional (PMP) training/certification preferred.
Responsibilities
- Lead, develop, and implement supplier/purchasing controls and associated activities including Approved Supplier List management.
- Support supplier selection, qualification, ongoing monitoring, and orderly disengagement when needed.
- Support component qualification for NPI projects at EP with cross-functional teams and suppliers
- Own, drive, and lead the assigned Supplier Quality related projects, activities, initiatives with limited supervision.
- Partner with Procurement, R&D, Engineering/Technical Operations, Quality, Operations, and Suppliers in the timely investigation, resolution/prevention of supplier-related issues to minimize/prevent business disruptions.
- Implement supplier change management process including component/ finished good qualifications, change notification, dissemination of information, impact assessment, approval of changes, and supports material/supplier qualifications.
- Supports and sustains robust supplier management programs for designated manufacturing and development activities
- Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.
Benefits
- 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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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
