Senior Quality Engineer

Johnson & Johnson Innovative Medicine•Irvine, CA

2d•$79,000 - $127,650•Onsite

About The Position

Biosense Webster a member of Johnson & Johnson's Family of Companies, is recruiting for an Senior Quality Engineer-NPD! This position will be located in Irvine, CA. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech The Senior Quality Engineer – plans, coordinates and executes quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product. Involved in New Product Development (NPD) teams and other activities to develop products, design verification tests, process validations and quality processes to ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards. As needed, assists to develop quality-engineered systems and products, and support qualification and validation activities. Will be considered an authority (SME) on Quality matters, relevant Quality tools and will work on complex problems and projects. Will show leadership in driving program/projects and innovating compliant approaches and solutions to problems. Shares technical expertise with others and develop other specialists. A few of the responsibilities may involve collaborating with other members of the Design Team. Will contribute to activities including risk management document development, creation, and design of catheter test methods, authoring of test protocols, and testing of products during their development cycle.

Requirements

A minimum of a Bachelor’s degree, required; preferably in engineering and/or scientific field
A minimum of 4 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry
Ability to define problems, collect and analyze data, establish facts, and draw conclusions and recommendations
Ability to use broad knowledge of regulatory, technical, and business requirements to conduct due diligence assessments
Ability to apply project management skills to ensure fulfillment of new product development requirements
Ability to develop and implement Quality standards
Proven auditing and problem-solving skills
Knowledge of groundbreaking Quality Engineering, design control, and verification and validation (V&V) tools and methodologies
Ability to effectively collaborate and connect with internal and external partners at all levels of the organization including influencing and negotiating resulting in positive business and quality outcomes.
Understanding of theoretical and practical fundamentals and experimental engineering techniques such as DOE, DMAIC and ANOVA.
Six Sigma/ Design for Six Sigma experience, and/or knowledge of Process Excellence tools
Lean manufacturing experience
Knowledge of Quality and operations systems and processes, including GMP
Geometrical Dimensioning and Tolerancing (GD&T) experience with an understanding of ASME Y14.5.
Ability to travel up to 20% for local, domestic or international business support is required

Nice To Haves

Proven understanding of SolidWorks, other CAD based programs (i.e.. basic dimensioning, tolerance stack analysis) is a plus.
Experience with Minitab, R and other statistical software is a plus.

Responsibilities

Working with other functional groups, including R&D and Operations in support of new product development, engineering projects, quality assurance activities, and lifecycle management.
Using Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
Oversight, from a Quality NPD perspective, of the Non-Conformance Report (NCR) process for BWI facilities located in the U.S.
Develop and establish effective quality control and support associated risk management plans, AFMEA, DFMEA and PFMEA.
Write, review and/or approve process and product validation protocols and reports, equipment qualifications, engineering change orders.
Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, Statistical Process Control (SPC), Design of Experiments (DOE), etc.).
Performs statistical analysis of data generated including but not limited to: Gauge R&R, ANOVA, Sample Size determination and variable/attribute data analysis against predetermined acceptance criteria.
Ensure that development activities follow design control requirements (Design Trace Matrix), product is tested per applicable standards, GSPR are met per the MDR, and product is accurately transferred to manufacturing per applicable specifications.
Technical problem solving, failure analysis, and root cause determination.
Makes decisions independently on engineering problems and methods and represents the organization in conferences to resolve important questions and to plan and coordinate work.
Recommend issue resolution to management for significant capability and compliance issues.
Works closely with functional leadership in planning and driving project breakthroughs.
Plans, develops, coordinates, and directs one or more large important engineering projects or a number of small projects with many sophisticated features.
Carries out sophisticated or novel assignments requiring the development of new or improved techniques or procedures.
Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment, when necessary, data are insufficient or confirmation by testing is advisable.
Responsible for communicating business related issues or opportunities to next management level
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
For those who supervise or lead staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Performs other duties assigned as needed

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)).
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