Quality Engineer II

Biopharma Careers; Santa Clara (CA); On-site; USD 105,000 - 115,000; Full time

Job summary

Shockwave Medical Inc. in Santa Clara, CA, seeks a Quality Engineer II to develop and maintain quality standards for processing materials into finished products. You will design inspection methods, support manufacturing, and drive cross-functional problem solving to ensure product quality.

Requirements include a Bachelor's degree in Bioengineering or Biomedical Engineering and 2 years in a related role. Experience with medical devices, non-conformance investigations, IQ/OQ/PQ, DOE, and FMEA is

Qualifications

• Bachelor's degree in Bioengineering, Biomedical Engineering or related field.
• 2 years of experience in Quality Engineer II-related occupation or equivalent.
• Experience in medical devices, non-conformance investigations and process validation.

Responsibilities

• Develop and maintain quality standards for processing materials into finished products.
• Design and implement inspection, testing and evaluation methods.
• Support manufacturing and work cross-functionally to resolve technical problems.
• Participate in risk management documentation including FMEA and DV/V&V.
• Contribute to audits, deviation investigations and change control processes.

Skills

Statistical analysis

Risk management

Documentation

Cross-functional

Quality systems

Education

Bachelor's degree in Bioengineering or Biomedical Engineering

Tools

Minitab

IQ/OQ/PQ

FMEA

Job description

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Employer: Shockwave Medical Inc.

Job Title: Quality Engineer II

Job Code: A011.10374

Job Location: Santa Clara, CA

Job Type: Full-Time

Rate of Pay: $105,000 - $115,000 per year

Job Duties:

Develop, apply, revise and maintain quality standards for processing materials/products into partially or finished products. Design and implement methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products, components, sub-assemblies and/or production equipment. Support manufacturing and work cross-functionally to resolve technical problems. Participate in decisions on scope of work, risk management, design changes, process improvements, material disposition, and implementation of revised specifications. Process, investigate, and complete customer complaints. Prepare documentation for inspection/testing procedures, development studies, validation protocols and reports, quality plans, product defect investigations and inspection plans. Assess if components, sub-assemblies, and products meet specification and can initiate, investigate, and resolve non-conformances by working in conjunction with a multidisciplinary team. Participate in developing the risk management documentation including (Hazard assessment, design trace matrix development, DV&V testing, and FMEA). Practice company safety, quality policies and procedures and participate in internal/external audits.

Requirements:

Employer will accept a Bachelor's degree in Bioengineering, Biomedical Engineering or related field and 2 years of experience in the job offered or in a Quality Engineer II-related occupation.

Position requires experience in:

1. Medical device industry;
2. Performing failure/ Product Non-conformance investigations;
3. Production line support including non-conformance investigation and product disposition, supporting process changes and process validation activities including IQ, OQ, and PQ;
4. Technical writing skills for investigations, design and process verification and validation protocols and reports;
5. Developing risk management documentation including plans, hazard assessment, design trace matrix development, DV&V testing, and FMEA;
6. Conducting statistical analysis using minitab or equivalent tools for process capability and data normality assessments, analysis of variance, and hypothesis testing, determining appropriate sample sizes, tolerance interval assessments for variable and attribute data, design of experiment (DOE), and variable and attribute sampling plan applications; and
7. ISO, ASTM, and FDA standards for quality within the medical device industry.

This job posting is anticipated to close on 10/26/2026.

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 https://www.jnj.com/contact-us/careers 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 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 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: - https://www.careers.jnj.com/employee-benefits