More jobs:
Quality Engineer NPD
Job in
Irvine, Orange County, California, 92713, USA
Listed on 2026-07-24
Listing for:
6010-Biosense Webster Inc. Legal Entity
Full Time
position Listed on 2026-07-24
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering -
Engineering
Quality Engineering
Job Description & How to Apply Below
Job Details
Location:
Irvine, California, United States of America
Job Function:
Quality – Quality Assurance
Job Category:
Professional
- Participate in new and sustaining product/process teams to support design verification tests, process validations, and quality processes.
- Involve in New Product Development (NPD) teams and related activities to develop products, design verification tests, process validations, and quality processes.
- Assist in developing quality‑engineered systems and products, and support qualification and validation activities.
- Work on complex problems and projects, innovating compliant approaches and solutions.
- Carry out calculations and document test results.
- Write or review technical reports, develop charts, graphs, schematics, and drawings to illustrate improvement processes.
- Ensure tools and test equipment are calibrated and repaired.
- Make recommendations on improving quality, efficiency, and cost of company products and processes.
- Ensure all documentation is recorded properly and follows procedures.
- Collaborate with R&D, Operations, and other functional groups in new product development, engineering projects, QA activities, and lifecycle management.
- Utilize quality engineering tools/processes in the development, implementation, transfer, and maintenance of products/processes throughout the lifecycle.
- Lead continuous quality and customer satisfaction improvement initiatives.
- Support the Non‑Conformance Report (NCR) process for U.S. BWI facilities.
- Develop and establish effective quality control and risk‑management plans, including AFMEA, DFMEA, and PFMEA.
- Write, review, and approve process and product validation protocols, reports, equipment qualifications, and engineering change orders.
- Use statistical tools such as Six Sigma, SPC, and DOE to analyze data and improve process capability.
- Ensure development activities comply with design control requirements, applicable standards, and transfer to manufacturing specifications.
- Perform technical problem solving, failure analysis, and root‑cause determination.
- Make independent decisions on engineering problems and represent the organization in conferences and meetings.
- Assess feasibility and soundness of proposed engineering evaluation tests, products, or equipment.
- Assign or review quality inspection testing and test data.
- Keep the department supervisor informed of activities and issues.
Base Pay Range: $65,000.00 – $
Benefits- Vacation – 120 hours per calendar year
- Sick time – 40 hours per calendar year (48 hours for Colorado residents, 56 hours for Washington residents)
- 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 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 period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time‑Off – 80 hours per calendar year
- Participation in the Company’s consolidated retirement plan and 401(k) plan
- Eligibility for the long‑term incentive program
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