Staff Quality Engineer - Quality LCM

Johnson & Johnson Innovative Medicine•Irvine, CA

6d•$125,000 - $150,000•Hybrid

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at jnj.com. 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. Employer: Biosense Webster, Inc.

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.

Responsibilities

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.

Benefits

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.