Johnson & Johnson MedTech · 23 hours ago
Sr. Supplier Quality Development Engineer (2 openings)
Santa Clara, CA
Full-time
Onsite
Mid, Senior Level
$109K/yr - $175K/yr
6+ years expJohnson & Johnson MedTech is a leader in healthcare innovation, focusing on developing advanced solutions for complex diseases. They are seeking a Sr. Supplier Quality Development Engineer to drive supplier readiness and quality for essential components in surgical robotics systems.
Hospital & Health Care
Responsibilities
Lead supplier onboarding activities: including selection, risk assessment, quality agreements, supplier audits, and supplier system setup across Johnson & Johnson’s enterprise platforms
Collaborate across sourcing, engineering, and operations to develop supplier capabilities aligned with program requirements and timelines
Conduct or facilitate supplier quality audits and support quality system gap closure and development planning
Drive nonconformance investigations, working directly with suppliers to lead root cause analysis and implement effective corrective and preventive actions
Monitor supplier performance data, conduct trend analysis, and find opportunities for continuous improvement or risk mitigation
Lead Supplier Change Notification (SCN) reviews, ensuring proper risk assessment, cross-functional alignment, and implementation controls
Initiate and manage Supplier Corrective Action Requests (SCARs) and track timely, robust resolution
Own and facilitate part qualification activities (PQP), including requirement review, risk management, Process Flow Diagrams, pFMEA, First Article Inspections, GR&R, Control Plans, Capability Studies, Inspection Planning, and Process Validation
Support internal and external audits (e.g., FDA, Notified Body) and represent supplier quality elements as needed
Participate in decisions that are aligned with management objectives regarding work processes, plans, and schedules to achieve department objectives
Tracks and report progress across projects and department commitments by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans
Monitors compliance with company policies, procedures, and applicable regulatory requirements
Qualification
Required
Bachelor's degree in Engineering or related technical field
Minimum 6 years of experience in supplier quality, manufacturing, or quality engineering roles
Proficient in 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
Proficiency with GD&T and its impact on inspection planning and MSA
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.
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 MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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