Quality Engineer

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. We respect the diversity and dignity of our employees and recognize their merit.

Role:
Staff Quality Engineer – Milpitas, CA

Function:
Supply Chain Engineering | Sub-Function:
Quality Engineering | Category:
Scientific/Technology

• Manufacturing Quality Support – Serve as the quality engineering lead supporting manufacturing operations.
• Partner with Manufacturing, Operations, Engineering, Supply Chain, and Regulatory Affairs to ensure product quality and compliance.
• Drive timely investigation and resolution of manufacturing nonconformances using structured problem-solving methodologies.
• Lead root cause investigations utilizing tools such as 5 Why, Fishbone, Fault Tree Analysis, DOE, and statistical analysis.
• Analyze quality metrics and manufacturing trends to identify opportunities for risk reduction and continuous improvement.

• Quality Systems – Lead and support Quality System processes; ensure compliance with FDA 21 CFR Part 820, ISO 13485, applicable international regulations, and internal procedures.
• Participate in Quality System improvements to enhance efficiency, compliance, and effectiveness.

• Audit & Regulatory Support – Lead/support investigations and corrective actions resulting from internal and external audits.
• Develop effective CAPAs addressing systemic root causes; ensure timely closure of audit observations.
• Support inspection readiness activities and regulatory inspections.

• Continuous Improvement – Identify and lead strategic quality improvement initiatives to enhance product quality, manufacturing efficiency, compliance, and customer satisfaction.
• Utilize Lean, Six Sigma, and risk-based decision-making methodologies to eliminate waste and improve process capability.
• Develop quality metrics and dashboards to monitor process effectiveness.

• New Product Introduction (NPI) – Provide quality engineering leadership during new product development and commercialization.
• Review design documentation and manufacturing readiness prior to Design Transfer.
• Collaborate with R&D, Manufacturing Engineering, Regulatory Affairs, and Operations to identify manufacturing and quality risks early in development.
• Support Design Transfer activities including process validation, manufacturing readiness reviews, inspection strategy development, control plans, risk assessments, and manufacturing documentation.
• Ensure successful transition of products from development into manufacturing.

• Technical Leadership & Mentorship – Serve as a technical resource and mentor for Quality Engineers; provide guidance on quality engineering principles, investigations, risk management, and regulatory compliance.
• Review technical work products for quality, consistency, and adherence to standards; promote knowledge sharing and continuous development across the Quality organization.
• Influence cross-functional teams without direct authority to achieve business objectives.

• Education – Bachelor’s Degree in Engineering or related technical discipline.
• Required Skills & Experience – Minimum 8 years in the medical device industry with knowledge of 21 CFR 820 and ISO 13485; demonstrated knowledge of FDA 21 CFR Part 820; ISO 13485;
  Risk Management (ISO 14971); CAPA;
  Nonconforming Material;
  Root Cause Analysis;
  Design Controls;
  Design Transfer; experience supporting manufacturing operations in a regulated environment; experience leading cross-functional quality improvement initiatives; strong analytical and…