Vacancy

Software Quality Engineer (Medical Devices)

United States Life Sciences San Francisco Remote

In this exciting role as a Software Quality Engineer, you will Witness cutting edge surgical navigation and robotic technologies designed to alleviate pain, restore health and extend life.

About The Member Company

We are a global high-tech consultancy company with a team of entrepreneurial engineers, scientists, and digital experts from around the world. Together we form a fast-growing and proud community. We offer consultancy services to high-profile clients globally in diverse service areas, such as:

  • Technology & Engineering
  • Energy & Renewables
  • Life sciences & Pharma
  • Digital & IT

About this vacancy

What you will be doing:

  • Collaborate with product development teams, including software, system, test, and senior software quality engineers, to develop new software releases.
  • Provide quality oversight and recommendations to improve product design quality.
  • Support Design and Use/Mis-Use Failure Mode and Effects Analysis.
  • Perform software defect disposition.
  • Investigate and review customer complaints, ensuring thorough root cause investigations.
  • Conduct software-related Corrective and Preventive Actions (CAPA) root cause analysis and investigations.
  • Ensure product quality and reliability, ensuring medical devices' safety, effectiveness, and regulatory compliance.
  • Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures.
  • Evaluate software systems activities, including requirements, design, development, documentation, integration, test, verification, and validation.
  • Ensure projects and process control documentation comply with requirements, objectives, and/or contracts.
  • Provide quality representation during software issue disposition forums.
  • Support internal and external audits by regulatory agencies as needed.
  • Regularly interact with computers, peers, and co-workers while performing duties independently.

What we expect from you

  • Bachelor’s Degree in Engineering, Science, or a technical field with 2 years of experience in Engineering and/or Quality OR an Advanced Degree in Engineering, Science, or a technical field.
  • Versatility, flexibility, and a willingness to work within constantly changing priorities.
  • Strong verbal and written communication skills; ability to present issues, plans, and objectives clearly.
  • Experience with Medical Devices.
  • Excellent organizational, problem-solving, and analytical skills.
  • Proficiency with Python, Java, JavaScript, Selenium, or C#.
  • 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.
  • ASQ certification as a Software Quality Engineer.

What you can expect from us

At TMC we believe that people are the driving force behind technological innovation. That is why we want to create the best possible conditions for tech talents to thrive in. We offer you a challenging and stimulating work environment in which you can be the director of your own career. As an Employeneur you are part of our TMC family. Next to our outstanding technical expertise, fun and engagement are meaningful parts of our culture.Why choose Employeneurship? We are truly unique thanks to our Employeneurship model which is a true innovation for the High Technology consulting business. It is the business relationship of the 21st century for high skilled technical professionals. It is built around 5 main principles:

The 5 basic principles of employeneurship
A long-term working relationship

Enjoy the security of a long-term contract and a stable source of income while getting the opportunity to work at diverse projects.

Individual profit sharing

Full transparency. That’s it. For each of your projects, you know your hourly rate, your costs, and your individual performance-based profit sharing, all in order to stimulate your inner entrepreneur.

Business cells

Our employeneurs are grouped in business cells based on their technical expertise. They are small, focused and function as high-grade knowledge networks. And as buzzing communities of close colleagues.

YOUniversity

Every employeneur drives their own career. Together, we make a plan for personal and professional growth. Receive personal coaching and an extensive training budget to keep developing yourself and deliver outperformance at our clients.

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The Entrepreneurial Lab

Work on your technical dreams in our lab. Collaborate with others in multidisciplinary teams to unlock out-of-the-box thinking and innovative ideas as well as entrepreneurial skills.

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Submit my application

Great that you are interested in a job at TMC! Apply now in the way that suits you best and hopefully we can welcome you to one of our teams soon.

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