Supplier Quality Engineer II- Shockwave Medical
Content + Source + Freshness • 12 Dec 2025 • 95% confidence
Offer value
High value score is indicated by competitive salary, significant responsibilities in a renowned healthcare company, and opportunities to impact patient outcomes.
- Competitive salary: $73,000 - $117,300/year
- Work with a leader in healthcare innovation
- Direct impact on patient care and quality assurance
- Requires experience in medical quality processes
Pros
- Competitive salary range ($73,000 - $117,300/year) in the medical device sector.
- Opportunity to work with a leading company in healthcare innovation.
- Role directly impacts quality outcomes in medical device manufacturing.
Cons
- Onsite work requirement may deter remote work seekers.
- Must manage multiple priorities in a fast-paced environment.
- Limited travel opportunities may restrict experiences.
Who it's for
Mid-level • Onsite
Good fit
- Mid-level Quality Engineers in medical devices
- Professionals experienced in supplier management
- Individuals passionate about healthcare technology
Not recommended for
- New job seekers or recent graduates
- Candidates looking for fully remote positions
- Individuals lacking relevant technical knowledge
Motivation fit
Key skills
About the job
- Job title Supplier Quality Engineer II- Shockwave Medical
- Function Supply Chain Engineering
- Sub function Quality Engineering
- Category Engineer, Quality Engineering (ST4 – E24)
- Location Santa Clara / United States of America
- Date posted
- Requisition number R-041530
- Work pattern Fully Onsite
Description
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 MedTech, 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. Learn more at https://www.jnj.com
Job Function:
Supply Chain EngineeringJob Sub Function:
Quality EngineeringJob Category:
Scientific/TechnologyAll Job Posting Locations:
Santa Clara, California, United States of AmericaJob Description:
Johnson & Johnson is hiring for a Supplier Quality Engineer II – Shockwave Medical to join our team located in Santa Clara, CA.
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 MedTech, 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. Learn more at https://www.jnj.com/.
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
Position Overview
The Supplier Quality Engineer II performs work with general supervision to provide and implement solutions to defined problems and assignments. The scope of responsibilities includes supporting manufacturing operations, managing suppliers, and working with cross-functional groups to address quality issues. The Supplier Quality Engineer II participates in decisions related to scope of work, risk management, process improvements, material disposition, and the implementation of revised product specifications.
Essential Job Functions
Supplier Management
- Partner with Procurement, R&D, Operations, Quality, and Suppliers in the timely investigation, resolution, and prevention of supplier quality issues which could disrupt business operations
- Monitor and analyze supplier performance metrics, identify improvement opportunities, and communicate supplier risks and/or opportunities to the next management level
- Participate in the planning, scheduling, execution, and reporting of supplier audits
- Participate in the initiation, issuance, review, and approval of Supplier Corrective Action Reports (SCARs)
- Drive corrective actions for supplier processes by driving suppliers to true root cause analysis and corrective and preventive actions
- Participate in component qualification change projects in collaboration with key business partners and the supplier’s applicable functional groups
- Compile, analyze, and summarize supplier performance data for Supplier Scorecards
Manufacturing Support
- Review, investigate, disposition, and drive to completion Non-conforming Reports (NCRs) and Corrective and Preventive Actions (CAPAs)
- Initiate, review, and approve Document Change Orders (DCOs)
- Provide technical support and guidance to the Quality Control group
- Collaborate with Manufacturing Engineering on process improvement projects
- Investigate customer complaints and document investigation findings
- Participate in internal and third-party audits (FDA, Notified Body)
- Participate in Material Review Board (MRB) meetings
Manufacturing Line Transfers
- Assist in defining requirements and generating documentation for the transfer of manufacturing lines to Contract Manufacturers (CMs)
- Assist in planning and providing on-site and off-site training to CMs on product inspection and testing
- Monitor product quality and production rates at CMs and assist in the resolution of production line issues
- Requirements J&J Credo: Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.
- Other duties as assigned
Qualifications
- BS degree in a related engineering discipline and 3+ years of related experience, or
- MS degree in a related engineering discipline
- Experience in the medical device industry is strongly preferred
- Knowledge of cGMP, FDA 820 QSR, ISO 13485, or other Quality Systems
- Strong technical writing skills
- Effective communication skills across all levels of the organization
- Must be proactive, self-motivated, and able to work independently with minimal supervision
- Ability to work independently in a fast-paced environment while managing multiple priorities
- Knowledge of statistics (hypothesis testing, capability analysis, DOE, MSA), Six Sigma, Lean
- Certifications (CQE, Lead Auditor, Six Sigma, Project Management) would be a plus
- Ability to travel up to 10% of the time
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Customer Centricity, Data Savvy, Document Management, Execution Focus, Good Automated Manufacturing Practice (GAMP), Issue Escalation, Lean Supply Chain Management, Process Control, Process Improvements, Quality Control (QC), Quality Services, Quality Standards, Quality Systems Documentation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically SavvyThe anticipated base pay range for this position is :
$73,000- $117,300Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. 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. 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 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 Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
