Software Quality Engineer (Medical Devices)

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Written by AI from the job title and company, not by TMC, so some details may not match this job. The employer's own page has the real description.

Job Overview

The Software Quality Engineer in Medical Devices at TMC plays a pivotal role in ensuring the highest quality standards for software used in medical devices. This position involves developing and executing software verification and validation plans, identifying defects in software designs, and ensuring compliance with regulatory requirements. The ideal candidate will work closely with cross-functional teams to ensure that all aspects of the software lifecycle are thoroughly tested, documented, and compliant with industry standards. The Software Quality Engineer will also contribute to continuous improvement initiatives aimed at enhancing product quality and patient safety.

Job Responsibilities

• Develop, implement, and maintain software verification and validation processes.
• Create and execute test plans, test cases, and test scripts for medical device software.
• Identify, document, and track software defects and issues through resolution.
• Collaborate with software development teams to ensure clear requirements and specifications are met.
• Conduct risk assessment and management related to software quality.
• Ensure compliance with applicable regulatory standards, including ISO 13485 and FDA regulations.
• Participate in design reviews and provide input related to quality assurance standards.
• Contribute to the development of process improvement initiatives that enhance software quality.

Qualifications

• Bachelor's degree in Computer Science, Software Engineering, or a related field.
• Minimum of 3 years of experience in software quality assurance and testing, preferably within the medical device industry.
• Strong knowledge of software testing methodologies, tools, and processes.
• Familiarity with regulatory standards and guidelines related to medical device software (e.g., ISO, FDA).
• Proficiency in test automation tools and programming languages (e.g., Python, Java).
• Excellent analytical and problem-solving skills.
• Strong communication skills, both verbal and written, with the ability to work collaboratively in a team environment.

Technologies & Tools

The Software Quality Engineer role utilizes various technologies and tools, including but not limited to, automated testing frameworks such as Selenium and JUnit, software development environments like Eclipse or Visual Studio, and version control systems such as Git. Familiarity with defect tracking tools like JIRA and test management software will also be essential, alongside knowledge of scripting languages for automation purposes.

Ideal Candidates

Ideal candidates for the Software Quality Engineer position at TMC are detail-oriented individuals who possess a passion for quality assurance in the medical device industry. They should showcase strong analytical skills, a problem-solving mindset, and the ability to work effectively under pressure. The perfect candidate is proactive in identifying issues and implementing solutions while exhibiting strong collaboration skills to work across various departments. Having a commitment to excellence and patient safety is paramount, as well as a willingness to embrace continuous learning and adaptability in a fast-paced environment.