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 https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Irvine, California, United States of America

Job Description:

Biosense Webster a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Engineer 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

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.

Key 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 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 the department supervisor abreast of activities and issues of the quality group.
• Additional Duties:
• 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 manage a 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

Qualifications

Education:

• A minimum of a Bachelor’s degree, required; preferably in engineering and/or scientific field

Experience and Skills:

Required:

• 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
• Proven auditing and problem-solving skills
• Knowledge of leading-edge 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.

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 preferred
• Six Sigma/ Design for Six Sigma experience, and/or knowledge of Process Excellence tools is helpful
• Lean manufacturing experience
• Knowledge of Quality and operations systems and processes, including GMP

Other:

• Ability to travel up to 20% for local, domestic or international business support is required

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

The anticipated base pay range for this position is :

$69,500-$102,350

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be 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 may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.