Quality Engineer II

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.

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 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, pleas