Job Description
Reviewing business and technical specifications to write and execute manual test scripts for quality assurance testing.
Defining test strategy, execute test plans, review tests product specifications and participate in defining/selecting appropriate test tools and automation strategy. work closely with SW/HW Program Management, and Operations to test and roll out the releases. Handle and support dynamic schedule, multiple environments, test cycles and deployments.
R&R
-Review specifications and technical design documents to provide timely and meaningful feedback for V&V activities.
-Owner & maintain company’s V&V dept.
-Create detailed, comprehensive and well-structured V&V test protocols and reports, with the ability to maintain and cross-reference it with Risk Analysis Matrix & Design Control documentation.
-Develop, apply & maintain test methods, equipment and instruments for the medical device throughout all development and production stages of the product to meet user needs & product requirements.
-Being involved in the reliability and integration tests for prototypes and products.
-Maintain relevant chapters of DHF & DMR.
-Development and implementation of methodologies for collecting and analyzing field failure data and determining root cause of field failures
-Coordinating failure analysis with other disciplines as necessary to lead to determination of root cause.
-Ensuring corrective actions are implemented in manufacturing to prevent recurrence of failure.
-Incorporating automation and improvement of failure analysis process.
70% hands on 30% team lead
Experience
– 3 Years of proven V&V LEAD experience in medical device industry -must
– Strong emphasis on problem solving
-Knowledge and experience with Medical Device Quality Systems, ISO 13485, FDA/CE submission-MUST
-Strong technical orientation for understanding multi- disciplinary system that includes device (HW/SW), mobile app and cloud infrastructure.
-Good documentation skills and ability to communicate effectively at all levels of the organization.
-Can conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities. Ability to effectively prioritize and execute tasks in a high-pressure environment.
Excellent skills in English language are required (verbal and written communication).