Supplier Quality Engineer II

Shockwave Medical; Santa Clara (CA); On-site; USD 170,000 - 171,000; Full time

Benefits offered by this job

Medical, dental, vision

Time off benefits

Retirement and savings plan

Job summary

Johnson & Johnson in Santa Clara, CA seeks a Supplier Quality Engineer II to partner with Procurement, R&D, Operations and Suppliers to ensure timely investigation, resolution and prevention of supplier quality issues.

The role requires a Bachelor's in engineering, 3+ years in supplier quality, strong experience with cGMP/FDA 820 QSR and ISO 13485, plus Six Sigma, Lean, and hands-on quality tools. The candidate will support MRB, CAPA, SCARs and supplier audits.

Qualifications

• Bachelor's degree in mechanical/industrial/manufacturing engineering or related field.
• Experience in medical device quality systems and regulatory requirements.
• Proficiency with quality tools and data analysis.

Responsibilities

• Investigate supplier quality issues and drive corrective actions.
• Participate in supplier audits and CAPA/SCAR processes.
• Support MRB decisions and documentation for transfers to contract manufacturers.

Skills

Statistical analysis

Six Sigma and Lean

Root Cause Analysis

GD&T

GDP

Metrology & inspection tools

Minitab

Education

Bachelor's degree in Mechanical Engineering / related field

Tools

SOLIDWORKS

Minitab

Job 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 jnj.com.

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. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Information

Job Function: Supply Chain Engineering

Job Sub Function: Quality Engineering

Job Category: Scientific/Technology

Location: Santa Clara, CA, United States of America

Employer: Shockwave Medical, Inc.

Job Title: Supplier Quality Engineer II

Job Code: A011.10389.2

Job Type: Full-Time

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

Responsibilities

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 and/or opportunities to upper management. 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 guiding suppliers through true root cause analysis and implementing corrective and preventive actions. Participate in component qualification and change projects in collaboration with key business partners and the supplier’s functional groups. Compile, analyze, and summarize supplier performance data for Supplier Scorecards. Review, investigate, disposition, and drive to 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.

Requirements

Bachelor's degree in Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, or a related field and at least 3 years of experience in the role offered or in a Supplier Quality Engineer II‑related occupation.

Required Experience With

• Medical device industry
• Quality Systems, including cGMP, FDA 820 QSR and ISO 13485
• Statistical analysis using Minitab (hypothesis testing, capability analysis, DOE, and 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 & Tolerancing (GD&T) for Engineering Drawings using SolidWorks
• Good Documentation Practices (GDP)
• Metrology and inspection tools (Calipers, MicroVu, Go/No‑Go Gages)

Lean Six Sigma Green Belt certificate required.

SOLIDWORKS 2019 Essential Training Certificate required.

This position is anticipated to close on 8/16/2026.

Benefits

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 (48 hours for Colorado residents, 56 hours for Washington residents)
• 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
• This position is eligible for benefits to include medical, dental, vision and time off, as well as any others provided under the applicable Collective Bargaining Agreement.
• For additional general information on company benefits, please visit https://www.careers.jnj.com/employee-benefits.

Equal Opportunity Employer

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.

Additional Employment Information

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.

Accommodation for Disabilities

If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.