Staff Quality Engineer Quality LCM

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: $125000 - $150000

Job Duties: Plan and coordinate quality assurance projects and activities throughout lifecycle of BWIs 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 companys 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 Masters 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 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: