Staff Software Quality Engineer
Company: Johnson & Johnson
Location: Santa Clara
Posted on: February 16, 2021
Robotics & Digital Solutions, part of the Johnson & Johnson Family
of companies, is recruiting for a Staff 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
The Staff 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 Auris 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
- 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 required.
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
- Bachelor of Science degree in Engineering, Computer Science or
- Minimum 8 years' experience with quality assurance with a focus
on software testing, design control of software development,
software verification and validation
- Minimum 5 years' experience in a quality role within the
medical device, aerospace / defense or similarly regulated
- Strong verbal and written communication skills; ability to
present issues, plans and objectives
- Excellent organizational, problem solving, and analytical
- Working knowledge of IEC 62304, FDA's General Principles of
Software validation, ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1
- Ability to manage priorities and workflow
- Versatility, flexibility, and a willingness to work within
constantly changing priorities
- Ability to travel up to 10%
- Advanced Degree
- ASQ certification as a Software Quality Engineer or Software
- Additional experience in functional areas outside of Quality
(e.g. IT, Research & Development, or New Product Introduction)
Keywords: Johnson & Johnson, Santa Clara , Staff Software Quality Engineer, IT / Software / Systems , Santa Clara, California
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