Johnson & Johnson MedTech · 1 day ago
Quality Engineer 1 NPD
Irvine, CA
Full-time
Onsite
New Grad, Entry Level
$59K/yr - $85K/yr
0+ years expJohnson & Johnson MedTech is focused on healthcare innovation, developing smarter, less invasive treatments. The Quality Engineer I will support new product development and quality processes, ensuring compliance with quality system policies and external standards while collaborating with various functional groups.
Hospital & Health Care
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
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 meaningful 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
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
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Performs other duties assigned as needed
Qualification
Required
Bachelor's degree, required; preferably in engineering and/or scientific discipline
0- 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 develop and implement Quality standards
Demonstrated auditing and problem-solving skills
Knowledge of leading-edge Quality Engineering, design control, and verification and validation (V&V) tools and methodologies is a plus
Ability to effectively collaborate and connect 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 is a plus
Preferred
Working knowledge of SolidWorks, other CAD based programs (ie. basic dimensioning, tolerance stack analysis) is a plus
Experience with Minitab, R and other statistical software is a plus
Six Sigma/ Design for Six Sigma experience, and/or knowledge of Process Excellence tools is a plus
Lean manufacturing experience is a plus
Knowledge of Quality and operations systems and processes, including GMP is a plus
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
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; 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
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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