Verification Lead - Medical Device Software QA

Gener8 | The RND Group; Indiana (PA); On-site; USD 120,000 - 160,000; Full time

Job summary

Gener8 | The RND Group in Indianapolis, IN is seeking a lead software tester for FDA-regulated medical devices. The role requires guiding testing activities and coordinating a testing team to ensure compliance and quality.

You will develop test cases from requirements, execute tests, and generate execution reports while gathering evidence for 510(k) submissions. Familiarity with FDA 21 CFR Part 820 and IEC 62304 is essential.

Qualifications

• Experience leading test efforts for software products.
• Ability to generate test cases from requirements for medical instruments.
• Experience executing tests and producing execution reports.
• Familiarity with evidence gathering for FDA submissions.
• Knowledge of FDA 21 CFR Part 820 and IEC 62304 is a plus.

Responsibilities

• Lead testing activities and supervise other testers as needed.
• Develop and maintain a traceability matrix.
• Execute test cases and generate detailed execution reports.
• Coordinate with stakeholders for documentation required for 510(k) submissions.
• Maintain alignment with FDA quality system regulations and IEC standards.

Skills

Lead testing experience

Test plan writing

Test case writing

Test execution

Traceability matrix

Defect tracking

Documentation process

Quality systems - ISO 14971

Quality systems - ISO 9000

IEC 62304

Communication skills

Project management

Education

Bachelor's degree in Biotechnology or related

Job description

Gener8 | The RND Group in Indianapolis, IN is seeking a lead software tester for FDA-regulated medical devices. The role requires guiding testing activities and coordinating a testing team to ensure compliance and quality.

You will develop test cases from requirements, execute tests, and generate execution reports while gathering evidence for 510(k) submissions. Familiarity with FDA 21 CFR Part 820 and IEC 62304 is essential.