Job Title: Software Quality Engineer
Location: Remote
Job Type: Full time + benefits
Company Summary:
TMC is an international high-tech consultancy company that brings expertise to their clients in order to support them with the realization of their technological challenges. As such, TMC is operating as an expert center at the disposition of its clients, and we help them to be more competitive in an ever more global and faster changing technological world.
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 you need to be successful:
Minimum Requirements:
- 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.
Preferred Qualifications:
- 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.
- 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 can you expect from TMC ?
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 pillars:
- You will be a permanent employee given opportunities to support multiple projects.
- You will get the opportunity to receive a share on the profit of your work.
- We will support you with a one-on-one coaching and trainings designed to help you develop your entrepreneurial skills.
- The competence cells within TMC will provide you with a strong, meaningful and relevant network.
- The entrepreneurial lab: a playground for new ideas and a potential launching for start-ups.
https://www.youtube.com/embed/gxzhX7TYvj4
TMC is an equal opportunity employer and values diversity. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Job Type: Full-time
Experience level:
Schedule:
Application Question(s):
- Do you have ASQ certification?
- How many years of experience do you have working as a Software Quality Engineer?
Experience:
- JavaScript: 4 years (Required)
- Selenium: 4 years (Required)
- Python: 4 years (Required)
- Java: 4 years (Required)
- Medical devices: 4 years (Required)
Work Location: Remote