Quality Engineer II

Johnson & Johnson•Irvine, CA

68d•$63,000 - $102,350•Onsite

About The Position

At Johnson & Johnson,â we believe health is everything. Our strength in healthcare innovation empowers us to build aâ world where complex diseases are prevented, treated, and cured,â where treatments are smarter and less invasive, andâ solutions are personal.â 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.â Learn more at https://www.jnj.com About MedTech 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 We are searching for the best talent for Quality Engineer II to work onsite at Irvine, CA. The Quality Engineer II supervises, executes, and coordinates 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 work on complex problems and projects. Will show leadership by innovating compliant approaches and solutions to problems. Shares technical expertise with others and develop other engineers.

Requirements

A minimum of a Bachelor's degree is required; Degree in engineering and/or scientific field is preferred.
A minimum of 2 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 develop and implement Quality standards
Demonstrated auditing and problem-solving skills
Knowledge of Quality Engineering, design control, and verification and validation (V&V) tools and methodologies
Ability to effectively collaborate and communicate with internal and external partners at all levels of the organization.
Understanding of theoretical and practical fundamentals and experimental engineering techniques such as DOE, DMAIC and ANOVA.

Nice To Haves

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
Working knowledge of CAD software (Solidworks, AutoCAD)

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.
Applying 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.
Leading efforts for continuous quality and customer satisfaction improvement opportunities.
Support Non-Conformance Report (NCR) process.
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.).
Support sterility, biocompatibility and packaging test requirements following company standard operation procedures for new products.
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 properly 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.
Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment.
Responsible for presenting business related issues or opportunities to next management levels.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

Benefits

employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance
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.
Vacation -120 hours per calendar year
Sick time - 40 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
Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave - 10 days
Volunteer Leave - 4 days
Military Spouse Time-Off - 80 hours