Staff Quality Engineer

Johnson & Johnson•Milpitas, CA

4d•Onsite

About The Position

The Staff Quality Engineer is a senior technical leader responsible for ensuring compliance with applicable medical device regulations and quality management system requirements while supporting manufacturing operations, quality systems, and new product introductions. This role provides technical leadership across complex quality initiatives, drives continuous improvement, leads resolution of quality issues, and mentors quality engineers to strengthen organizational capability.

Requirements

A minimum of a Bachelor’s Degree in Engineering or related technical discipline.
A minimum of 8 years of work experience
Experience in medical device industry with knowledge of 21 CFR 820, 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 problem-solving skills.
Excellent written and verbal communication skills.

Nice To Haves

Industry experience with capital equipment
Lean Six Sigma Green Belt or Black Belt
Experience supporting FDA inspections and notified body audits
Advanced knowledge of Quality Engineering/Scientific Method techniques and principles
Applied statistics of increasing complexity

Responsibilities

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.
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.
Lead/ support investigations and corrective actions resulting from: Internal audits, External audits
Develop effective CAPAs that address systemic root causes.
Partner with cross-functional teams to ensure timely closure of audit observations.
Support inspection readiness activities and regulatory inspections.
Identify and lead strategic quality improvement initiatives that improve 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.
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, Manufacturing documentation
Ensure successful transition of products from development into manufacturing.
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 to ensure 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.
Other responsibilities may be assigned and not all responsibilities listed may be assigned

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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
consolidated retirement plan (pension)
savings plan (401(k))
long-term incentive program