Quality Engineer II
Job Location:
Santa Clara County, CA - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .
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 Function:
Supply Chain EngineeringJob Sub Function:
Quality EngineeringJob Category:
Scientific/TechnologyAll Job Posting Locations:
Santa Clara California United States of AmericaJob 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: $105000 - $115000 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 Bachelors 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 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:
Preferred Skills:
Required Experience:
IC
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
