Remote Med Device SW Design Quality Engineer

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

Overview

The Remote Med Device Software Design Quality Engineer at Kforce Inc. plays a crucial role in ensuring the quality and compliance of medical device software development. The ideal candidate will collaborate with cross-functional teams to establish and maintain quality assurance processes, implement best practices in software design, and ensure adherence to regulatory requirements. This position involves assessing the software lifecycle and executing audits, reviews, and validations to guarantee that products meet both internal and external standards.

Job Responsibilities

• Develop and implement quality assurance processes for software design and development within the medical device sector.
• Conduct software risk management and hazard analysis in compliance with relevant ISO and FDA guidelines.
• Review and approve software requirements specifications, design documents, and test plans.
• Perform audits and assessments to evaluate compliance with industry regulations and internal policies.
• Collaborate with software development teams to identify and resolve quality issues during the development lifecycle.
• Lead root cause analysis efforts and establish corrective action plans for identified quality problems.
• Provide training and support related to quality standards and best practices to internal teams.

Qualifications

• Bachelor’s degree in Computer Science, Biomedical Engineering, or a related field.
• Minimum of 3 years of experience in software quality assurance or related quality engineering roles within the medical device industry.
• Strong knowledge of software development lifecycle (SDLC) processes and tools.
• Familiarity with regulatory standards such as ISO 13485, IEC 62304, and FDA guidelines.
• Proficiency in developing and executing software test plans, protocols, and reports.
• Excellent analytical, problem-solving, and communication skills.

Technologies & Tools

The Remote Med Device Software Design Quality Engineer will utilize a variety of technologies and tools pertinent to software quality assurance, including but not limited to TestRail for test case management, JIRA for issue and project tracking, and various software development environments such as Visual Studio or Eclipse. Familiarity with automation tools like Selenium or similar frameworks is also beneficial, as well as proficiency in programming languages commonly used in software development.

Ideal Candidates

Ideal candidates for this position will demonstrate a strong commitment to quality and regulatory compliance, coupled with a proactive approach to problem-solving. They should possess effective communication skills, be team-oriented, and thrive in a remote work environment. A passion for continuous improvement and the ability to adapt to new technologies and methodologies are essential characteristics. Candidates should be detail-oriented and capable of managing multiple tasks in a dynamic setting while maintaining high quality standards.