• Support and lead QMS activities related to Document Control, QMS management, CAPA, Risk Management and Complaints • Lead and Implement improvements to drive compliance, quality, and efficiency of these processes • Investigate nonconformities and use appropriate tools to determine the root cause • Develop product knowledge to make informed decisions that influence product quality and safety • Support audits by promptly delivering complete and accurate records • Work with other stakeholders in the company to track and monitor successes and pain points of QMS processes • Participate in risk assessments, risk mitigation strategies and risk management plans

• The consultant will be an individual contributor.

• Read and understand software requirements and documentation • Create simple, organized, and clear test cases • Perform manual tests to validate features and bug fixes • Identify, document, and help track bugs • Re-test resolved issues and assist with regression testing • Participate in Agile team meetings and collaborate with developers and product managers

• Collaborate with the engineering team to understand product requirements and design comprehensive test plans. • Develop, execute, and maintain automated and manual test cases to ensure software quality. • Identify, document, and track software defects and inconsistencies. • Perform regression testing to verify resolved issues and ensure the stability of the software. • Assist in the creation and maintenance of test data and test environments. • Work with cross-functional teams to troubleshoot and resolve software defects.