Quality Engineer 2 NPD

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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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.

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.

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