Quality Engineer 2 NPD

Johnson & Johnson Innovative Medicine•Irvine, CA

1d•$65,000 - $104,650•Onsite

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.

Requirements

Quality Assurance
Design verification tests
Process validations
Quality processes
New Product Development (NPD)
Company’s Quality System policies and procedures
Applicable external requirements and standards
Quality-engineered systems and products
Qualification and validation activities
Complex problems and projects
Compliant approaches and solutions
Technical guidance on sophisticated problems
Calculations
Document test results
Technical reports
Charts, graphs, schematics and drawings
Tools and test equipment calibration and repair
Improving quality, efficiency, cost of company product(s), processes, and/or efficiency techniques
Documentation recording and procedures
Federal, state and local laws/regulations
Corporate Johnson & Johnson, procedures and guidelines
R&D and Operations collaboration
New product development
Engineering projects
Quality assurance activities
Lifecycle management
Quality Engineering tools/processes
Effective and efficient development, transfer, and maintenance of products/processes
Continuous quality and customer satisfaction improvement opportunities
Non-Conformance Report (NCR) process
Risk management plans
AFMEA
DFMEA
PFMEA
Process and product validation protocols and reports
Equipment qualifications
Engineering change orders
Statistical tools
Data analysis
Acceptance decisions
Process capability improvement
Six Sigma
Statistical Process Control (SPC)
Design of Experiments (DOE)
Design control requirements (Design Trace Matrix)
Product testing per applicable standards
GSPR per the MDR
Product transfer to manufacturing per applicable specifications
Technical problem solving
Failure analysis
Root cause determination
Engineering problems and methods
Feasibility and soundness of proposed engineering evaluation tests, products or equipment
Quality inspection testing
Test data

Responsibilities

Under general supervision, participate in new and sustaining product/process teams to support design verification tests, process validations, quality processes.
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.
Will receive technical guidance on sophisticated problems, but independently develops approaches and solutions.
Work is usually well defined and is checked for progress and reviewed for accuracy upon completion.
Carries out calculations and documents test results. Writes and/or reviews technical reports, develops charts, graphs, schematics and drawings to illustrate improvement processes. Ensures tools and test equipment are properly calibrated and repaired.
Makes recommendations on improving quality, efficiency, cost of company product(s), processes, and/or efficiency techniques. Ensures all documentation is recorded properly and follows procedures.
Working with other functional groups, including R&D and Operations in support of new product development, engineering projects, quality assurance activities, and lifecycle management.
Utilizing 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 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.).
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.
Assigns/reviews quality inspection testing and test data. Keeps department supervisor abreast of activities and issues of the quality group.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year (varies by state)
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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year