Quality Engineer

Robotics & Digital Solutions, part of the Johnson & Johnson family of companies, is recruiting for a Quality Engineer , located in Santa Clara, CA !

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/ .

Robotics & Digital Solutions is part of Ethicon, Inc., a global leader in surgery with products and solutions found in almost every operating room around the world. Ethicon has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including robotics, digital solutions, sutures, staplers, energy devices, trocars and hemostats and our dedication to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact! For more information, visit www.ethicon.com

The Quality Engineer is responsible for providing quality engineering support for the manufacture of capital systems. The ideal candidate has experience supporting complex electro-mechanical, software-controlled systems for medical applications. This individual will work with engineering and manufacturing operations teams within the company. This position requires knowledge of medical device regulatory environment (FDA, MDD, ISO 13485). Candidates should also have knowledge and experience to support equipment qualifications, process validations, manufacturing/testing requirements, Test Method Validation (TMV), protocol development, and risk management per FDA, ISO 14971, and other applicable medical devices standards.

Key Responsibilities:

• Supports and identifies improvement opportunities for Quality Engineering Supply Chain project plans, key milestones, and objectives, to ensure deliverables are aligned with customer's operational needs and requirements.

• Independently identifies any Quality Engineering non-conformance, subsequent corrective, and preventive actions, by documenting, investigating, and conducting root cause analysis, and successfully implementing corrective actions.

• Reviews documentation to ensure outputs adhere to quality, safety, and regulatory compliance requirements.

• Performs and/or reviews verifications/validations/qualifications (TMVs, process validations, IQ/OQ/PQ) for current and new processes.

• Develops product quality plans/protocols/engineering studies in conjunction with other quality or product development team members.

• Creates, updates, and/or reviews risk analyses and FMEA's.

• Supports training of Quality Assurance Specialists and Manufacturing Technicians to GDP, quality processes/procedures, and site-specific safety and industrial hygiene requirements.

• Communicates and escalates in a timely manner, any issues, or concerns uncovered to the next management level.

• Mentors more junior colleagues in techniques, processes, and responsibilities.