Quality Engineer 1 NPD
Quality Engineer 1 NPD
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Job Description
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at
Job Function:
Supply Chain EngineeringJob Sub Function:
Quality EngineeringJob Category:
Scientific/TechnologyAll Job Posting Locations:
Irvine California United States of AmericaJob Description:
About MedTech
Fueled by innovation at the intersection of biology and technology were 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 internal pre-identified candidate for consideration has been identified. However all applications will be considered.
We are searching for the best talent for Quality Engineer 1 NPD to be in Irvine California.
The NPD Quality Engineer 1 executes quality assurance activities intended to ensure effective product quality processes are in place and executed throughout the lifecycle of a product. Involved in NPD teams and other activities to develop products design verification tests process validations and quality processes to ensure compliance with the companys Quality System policies and procedures and applicable external requirements and standards. As needed assists in developing quality-engineered systems and products and support qualification and validation activities. Will show leadership in driving program/projects and innovating compliant approaches and solutions to problems. 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. If you are an individual who enjoys working with the other team members and changing the lives of our patients around the world come join our team!
SECTION 1: JOB SUMMARY
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 companys 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.
SECTION 2: DUTIES & RESPONSIBILITIES
In accordance with all applicable federal state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines this position:
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 practicesfor the effective and efficient development transfer and maintenance of products/processesthroughout 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 processcapability (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 perapplicable standards GSPR are met per the MDR and product isproperly 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 theorganization in conferences to resolve important questions and to plan and coordinate work.
Assesses the feasibility and soundness of proposed engineering evaluation tests products orequipment.
Assigns/reviews quality inspection testing and test data. Keeps department supervisor abreast of activities and issues of the quality group.
Additional Duties:
o Responsible for communicating business related issues or opportunities to next management level
o Responsible for following all Company guidelines related to Health Safety and Environmental practices as applicable.
o 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
o Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures
o Performs other duties assigned as needed
SECTION 3: EXPERIENCE AND EDUCATION
Bachelors 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
SECTION 4: REQUIRED KNOWLEDGE SKILLS ABILITIES CERTIFICATIONS/LICENSES and AFFILIATIONS
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 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 is a plus.
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.
About MedTech
Fueled by innovation at the intersection of biology and technology were 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 are searching for the best talent for Quality Engineer 1 NPD to be in Irvine California.
The NPD Quality Engineer 1 executes quality assurance activities intended to ensure effective product quality processes are in place and executed throughout the lifecycle of a product. Involved in NPD teams and other activities to develop products design verification tests process validations and quality processes to ensure compliance with the companys Quality System policies and procedures and applicable external requirements and standards. As needed assists in developing quality-engineered systems and products and support qualification and validation activities. Will show leadership in driving program/projects and innovating compliant approaches and solutions to problems. 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. If you are an individual who enjoys working with the other team members and changing the lives of our patients around the world come join our team!
Key Responsibilities:
Provide support in quality improvement opportunities as appropriate to new products continuous improvement and customer satisfaction.
Understand the investigation processes related to corrective and preventive action (CAPA) as well as nonconformances (NC) identification of root cause and recommend action(s). Generate nonconformance reports and assist in investigation final disposition and corrective action.
Use statistical tools to analyze data make acceptance decisions and improve process capability (Six Sigma SPC DOE).
Assign/review quality inspection testing and test data. Communicate activities and issues to supervisor.
Reviews documents for GDP.
Support audits.
Help execute and develop process and product validation/verification protocols and reports equipment qualifications and engineering change orders.
Qualifications
Education:
A minimum of a Bachelors degree with focus in engineering and/or scientific field is preferred. Alternatively 2 years of quality manufacturing or research and development experience in a medical device or other regulated industry.
Experience and Skills:
Required:
Ability to define problems collect and analyze data establish facts and draw conclusions and recommendations
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
Ability to function in a team environment and deliver on team objectives
Strong attention to detail
Preferred:
Familiarity with general quality management system concepts including good documentation practice (GDP) corrective and preventive action (CAPA) and document change control practices.
Developed presentation skills.
Understanding of theoretical and practical fundamentals and experimental engineering techniques such as DOE DMAIC and ANOVA.
Working knowledge of SolidWorks other CAD based programs (i.e. basic dimensioning tolerance stack analysis).
Experience with Minitab R and other statistical software.
Six Sigma or lean manufacturing experience and/or knowledge of Process Excellence tools.
Experience in Class III medical devices and/or cardiac products
Other:
This position may require up to 20% of domestic and/or international travel.
Additional Information:
The expected base pay range for this position is $59000 - $85000 annually
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 corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis.
This position is overtime eligible
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 Companys consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Companys long-term incentive program.
Employees are eligible for the following time off benefits:
o Vacation 120 hours per calendar year
o Sick time - 40 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year
o Holiday pay including Floating Holidays 13 days per calendar year
o Work Personal and Family Time - up to 40 hours per calendar year
o Parental Leave 480 hours within one year of the birth/adoption/foster care of a child
o Condolence Leave 30 days for an immediate family member: 5 days for an extended family member
o Caregiver Leave 10 days
o Volunteer Leave 4 days
o Military Spouse Time-Off 80 hours
Additional information can be found through the link below. job posting is anticipated to close on October 1 2025. The Company may however extend this time-period in which case the posting will remain available on to accept additional applications
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 () or contact AskGS to be directed to your accommodation resource
The anticipated base pay range for this position is :
59000 - 85000Additional Description for Pay Transparency:
Employment Type
Full-Time
