Job Function: Supply Chain Engineering
Job Sub Function: Quality Engineering
Job Category:Scientific/Technology
All Job Posting Locations:Milpitas, California, United States of America
Job Description:About MedTechFueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
We are searching for the best talent for a
Staff Quality Engineer in
Milpitas, CA.
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.
Responsibilities: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 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.
Continuous Improvement- 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.
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
- 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 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
Qualifications:Education -
- A minimum of a Bachelor's Degree in Engineering or related technical discipline.
Required Skills & Experience:- 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.
Preferred Skills & Experience:- 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
Other - - This role is based in Milpitas, CA and could require up to 10% domestic and international travel
Required Skills:Preferred Skills:The anticipated base pay range for this position is :$109,000.00 - $174,800.00
Additional Description for Pay Transparency:
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-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.
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
