What are the responsibilities and job description for the Senior Medical Devices Testing position at Cynet Systems?
Job Description:
Pay Range: $70hr - $75hr
Responsibilities:
Regulatory Compliance and Standards Adherence:
Pay Range: $70hr - $75hr
Responsibilities:
Regulatory Compliance and Standards Adherence:
- Relevant medical device regulations 8-10 years’ experience and expertise (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304) working in agile environment to ensure software testing practices comply with these standards and Organizational QMS standards.
- Document Compliance: Ensure that software testing QMS and compliance documentation meets regulatory requirements, including test plans, test cases, test reports, and defect tracking.
- Develop Test Plans: Create detailed test plans based on software requirements, design specifications, and regulatory guidelines. Define testing scope, objectives, and strategies.
- Design Test Cases: Develop comprehensive test cases and scenarios to validate software functionality, performance, and compliance with regulatory standards.
- Perform Testing: Execute manual and automated tests to verify software functionality, performance, and reliability.
- This includes functional testing, integration testing, system testing, and user acceptance testing.
- Verify Compliance: Ensure that software functions correctly in various scenarios and adheres to regulatory requirements for medical diagnostic devices.
- Detect Defects: Identify, document, and track software defects and issues.
- Collaborate with development teams to resolve defects and retest as necessary.
- Manage Defects: Use defect tracking tools to manage the lifecycle of identified issues, ensuring that they are addressed in a timely manner.
- Documentation and Reporting.
- Risk Management.
- Collaboration and Communication.
- Continuous Improvement.
- Validation and Verification (V&V).Training and Development.
- Bachelor’s degree in computer science, Engineering, Life Sciences, or a related field.
- Advanced degrees or certifications (e.g., ISTQB, CSTE) are a plus.
- 8-10 in medical device and life sciences software QMS testing, particularly in the medical device or diagnostic industry, with a strong understanding of regulatory requirements and quality standards.
- Technical Skills: Proficiency in test automation tools, programming languages, and software testing methodologies.
- Familiarity with medical device software development and testing standards.
- Attention to Detail: Strong analytical and problem-solving skills with a keen attention to detail to identify and address software issues.
- Communication Skills: Excellent verbal and written communication skills to effectively interact with development teams, regulatory bodies, and stakeholders.
- Regulatory Knowledge: In-depth knowledge of regulatory standards and guidelines relevant to medical device software, including risk management and compliance requirements.
Salary : $70 - $75
