Software Quality Engineer
- Santa Clara, CA
Robotics & Digital Solutions, part of the Johnson & Johnson Family of companies, is recruiting for a Software Quality Engineer located in Santa Clara, CA!
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 commitment 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 Software Quality Engineer is responsible for supporting product quality and reliability ensuring the implementation of cutting-edge technology for medical devices is safe, effective, and compliant with regulations, standards, and industry practices. Working closely with multi-functional teams this individual will act as an authority for both product and non-product software quality throughout the development lifecycle. The individual reviews and assesses software activities (e.g. user needs, software development plans, software requirements, software architecture and design, software verification and validation) to ensure that they comply with applicable procedures standards and regulatory requirements. Additional responsibilities may include but are not limited to supporting other areas of the Quality Management System such as CAPA, Complaints, software problem resolution and both Internal and External Audits.
- Review all project/program software deliverables (e.g. plans, requirements, specifications, test protocols, test cases, test results, traceability, risk management documents, reports).
- Provides direction and leadership for verification and validation of non-product software, products software, software tools and components.
- Provide expertise in establishing good software requirements, specifications, detailed design, verification and validation protocols and planning documentation.
- Collaborate with project / program teams to ensure software deliverable comply with RADS procedures, global ISO standards (ISO 13485, ISO14971, IEC62304), regulations (e.g. 21 CFR Part 820, 21 CFR Part 11, European Union Medical Device Directive (MDD)/ Medical Device Regulation (MDR), and applicable guidance.
- Provide Quality representation during software problem resolution. Participate in technical design reviews and project phase reviews.
- Utilize knowledge of risk management to ensure a risk-based approach for QMS processes.
- Identifies and implements any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system using quality policy, quality objectives, audit results, analysis of data, etc.
- Support internal audits and external audits by regulatory agencies, as the need arises.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this job/classification. They are not intended to be construed as a comprehensive list of all responsibilities, duties, and skills required of personnel so classified.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
- Bachelor of Science Degree in Engineering, Computer Science or related field
- Minimum 3 years' experience with quality assurance with a focus on software testing, design control of software development, software verification and validation
- Minimum 1 year experience in a quality role within the medical device, aerospace / defense or similarly regulated industry
- Strong verbal and written communication skills; ability to present issues, plans and objectives.
- Excellent organizational, problem solving, and analytical skills
- Working knowledge of IEC 62304, FDA's General Principles of Software validation, ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1 and MDD/MDR
- Ability to manage priorities and workflow
- Versatility, flexibility, and a willingness to work within constantly changing priorities
- Ability to do up to 10% travel
- Masters or Adv anced Degree
- ASQ certification as a Software Quality Engineer or Software Quality Auditor
- Additional experience in functional areas outside of Quality (e.g. IT, Research & Development, or New Product Introduction)
United States-California-Santa Clara-
Auris Health, Inc. (6267)
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