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Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Irvine, California, United States of America

Job Description: Employer:

Biosense Webster, Inc.

Job Title:

Staff Quality Engineer

• Quality LCM

Job Code:

A011.5768

Job Location:

Irvine, CA

Job Type:

Full-Time

Rate of Pay:

$125,000 - $150,000

Job Duties:

Plan and coordinate quality assurance projects and activities throughout lifecycle of BWI's products, primarily electrophysiology catheters, cables, and systems. Serve as subject matter expert on Quality LCM (Life Cycle Management) matters. Use Quality Engineering tools/processes in the development and implementation of practices for effective and efficient development, transfer, and maintenance of products, including manufacturing transfers, project management, shelf life evaluations, and compliance. Collaborate with QE-NPD, R&D, PMNPD, Operations/Supply Chain, BWI-Israel and other inter- and intra -departmental groups as needed in conducting functional role. Lead and support design verification tests, process validations, and quality processes to ensure compliance with the company’s Quality System policies and procedures, as well as applicable external regulatory agency requirements and standards, including FDA, ISO 13485, CMDCAS, and PMDA as pertains to medical devices. Drive quality assurance activities to ensure effective product quality processes are in place and executed throughout lifecycle of product. Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE). Provide all planning necessary to ensure effective product acceptance. Assist Regulatory Affairs in developing submissions for process changes, inspection changes, and new processes/devices as necessary. Participate in design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.

May telecommute 2 days per week.

Requirements:

Employer will accept a Master's degree in Mechanical Engineering, Biomedical Engineering, or related field and 4 years of experience in the job offered or in a Staff Quality Engineer

• Quality LCM-related occupation.

This job posting is anticipated to close on 5/22/2026.

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

Required Skills: Preferred Skills: