Quality Engineer NPD

Quality Engineer 1 NPD

Join to apply for the Quality Engineer 1 NPD role at Johnson & Johnson Med Tech.

Location:

Irvine, California, United States of America

• Job Function:
  Supply Chain Engineering
• Job Sub Function:
  Quality Engineering
• Job Category:
  Scientific/Technology

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 Med Tech, 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.

We are searching for the best talent for Quality Engineer I NPD to work onsite at Irvine, CA. Under general supervision, the Quality engineer I participates 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.

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.

• 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.
• 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…