Senior Quality Engineer – Medical Devices & NPI Leader
Job in
Milpitas, Santa Clara County, California, 95035, USA
Listed on 2026-07-20
Listing for:
6240-AMO Manufacturing USA LLC Legal Entity
Full Time
position Listed on 2026-07-20
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist -
Engineering
Quality Engineering, Regulatory Compliance Specialist, Biomedical Engineer
Job Description & How to Apply Below
Johnson & Johnson Milpitas site seeks a Staff Quality Engineer to lead manufacturing quality activities, drive CAPAs, and ensure compliance with FDA/ISO standards. You will guide NPI quality, design transfer, and cross-functional collaboration with R&D, regulatory, and operations.
The role requires 8+ years in medical devices, expertise in 21 CFR 820 and ISO 13485, and strong analytical/problem-solving skills. Travel up to 10% may be required.
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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