Quality Engineering 1

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

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.

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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 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 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 are searching for the best talent for Quality Engineering 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.

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. Appendix I Rev L CONFIDENTIAL use pursuant to Company Procedures Page 3 of 5

• 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:

• 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

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

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.

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