Supplier Quality Engineer II

Job Title:

Supplier Quality Engineer II

Job Code: A011.10389.2

Employer:

Shockwave Medical, Inc.

Location:

Santa Clara, CA

Job Type: Full-Time

Rate of Pay: $170,248 - $171,000 per year

• Partner with Procurement, R&D, Operations, Quality, and Suppliers to ensure timely investigation, resolution, and prevention of supplier quality issues that could disrupt business operations.
• Monitor and analyze supplier performance metrics, identify improvement opportunities, and communicate supplier risks or opportunities to management.
• Participate in the planning, scheduling, execution, and reporting of supplier audits.
• Initiate, issue, review, and approve Supplier Corrective Action Reports (SCARs).
• Drive corrective actions for supplier processes by guiding suppliers through root‑cause analysis and implementing corrective and preventive actions.
• Collaborate on component qualification and change projects with key business partners and supplier functional groups.
• Compile, analyze, and summarize supplier performance data for Supplier Scorecards.
• Review, investigate, disposition, and drive completion of 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 findings.
• Participate in internal and third‑party audits (e.g., FDA, Notified Body).
• Participate in Material Review Board (MRB) meetings.
• 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 resolving production line issues.

• Bachelor's degree in Mechanical Engineering, Industrial Engineering, Manufacturing Engineering or related field.
• Minimum three years of experience in a Supplier Quality Engineer II-related occupation or equivalent in the medical device industry.
• Experience with: medical device industry; quality systems including cGMP, FDA 820 QSR, and ISO 13485; statistical analysis using Minitab (hypothesis testing, capability analysis, DOE, MSA);
  Six Sigma and Lean Manufacturing;
  Process Validation/Equipment Qualification (IQ/OQ/PQ); risk management tools (dFMEA, pFMEA); root‑cause analysis, fishbone diagram, control charts and CAPA for non‑conforming materials; geometric dimension and tolerancing for engineering drawings using Solid Works; good documentation practices; metrology and inspection tools (calipers, Mic Vu, Go/No‑Go gages).
• Lean Six Sigma Green Belt certificate required.
• Solid Works 2019 Essential Training certificate required.

• Vacation: 120 hours per calendar year.
• Sick time: 40 hours per calendar year (48 hours in Colorado, 56 hours in Washington).
• Holiday pay: 13 days per calendar year including floating holidays.
• Work, personal, and family time: up to 40 hours per calendar year.
• Parental leave: 480 hours within one year of the birth, adoption, or 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 and 10 days.
• Volunteer leave: 32 hours per calendar year.
• Military spouse time‑off: 80 hours per calendar year.
• Eligible to participate in the company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Eligible for the company’s long‑term incentive program.
• Eligible for medical, dental, vision, and other benefits provided in the applicable collective bargaining agreement.
• Additional general information on company benefits:

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 & 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 contact us via  or contact AskGS to be directed to your accommodation resource.

This job posting is anticipated to close on 8/16/2026.