Senior Supplier Quality Dev Engineer

Company Overview

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 Med Tech, 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.

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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.

Quality

Supplier Quality

Professional

Irvine, California, United States of America

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.

• 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.

• 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., QSRs, 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.
• 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.

Analytics Reasoning, Business Behavior, Coaching, Compliance Management, Controls Compliance, Cross‑Functional Collaboration, Data Compilation, ISO 9001, Issue Escalation, Persistence and Tenacity, Problem Solving, Quality Control (QC), Quality Standards, Quality Systems Documentation, Report Writing, Technologically Savvy, Vendor Selection

Analytics Reasoning, Business Behavior, Coaching, Compliance Management, Controls…