Supplier Quality Engineer II

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Employer: Shockwave Medical Inc.

Job Title: Supplier Quality Engineer II

Job Code: A011.10389.2

Job Location: Santa Clara CA

Job Type: Full-Time

Rate of Pay: $170248 - $171000/year

Job Duties: 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 the next level of 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 suppliers applicable functional groups. Compile analyze and summarize supplier performance data for Supplier Scorecards. 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 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: Employer will accept a Bachelors degree in Mechanical Engineering Industrial Engineering Manufacturing Engineering or related field and 3 years of experience in job offered or in a Supplier Quality Engineer II-related occupation.

Position requires experience with:

1. Medical device industry;

2. Quality Systems including cGMP FDA 820 QSR and ISO 13485;

3. Statistical analysis using Minitab (hypothesis testing capability analysis DOE and MSA);

4. Six Sigma and Lean Manufacturing;

5. Process Validation/Equipment Qualification (IQ/OQ/PQ);

6. Risk Management Tools (dFMEA pFMEA);

7. Root Cause Analysis Fishbone Diagram Control Charts and Corrective Action Preventive Action (CAPA) for Non-Conforming Materials;

8. Geometric Dimension & Tolerancing (GD&T) for Engineering Drawings using SolidWorks;

9. Good Documentation Practices (GDP); and

10. Metrology and inspection tools (Calipers MicroVu Go/No-Go Gages).

Lean Six Sigma Green Belt certificate required.

SOLIDWORKS 2019 Essential Training certificate required.

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

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.

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Companys 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 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

This position is eligible for benefits to include medical dental vision and time off as well as any others as provided for in the applicable Collective Bargaining Agreement.

For additional general information on Company benefits please go to: - Skills:

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