Experience in working in Medical device development and design.
Good understanding on product sterility, biocompatibility, labeling & packaging standards.
Good understanding on Medical Quality Process and QA function.
Good understanding on IFU, packaging, sterilization Validation / Verification protocols and Versioning activity.
Experience in Change Management Process / Tracking and compliance with QMS requirements.
Assist project team to develop and maintain periodic status reports to keep management informed on project progress.
Excellent verbal and written skills necessary in order to effectively communicate complex issues.
Ability to maintain composure and adapt in a dynamic, fast-paced, customer-focused work environment characterized by rapid change, minimal lead times, and multiple competing priorities.
Ability to effectively manage and execute multiple tasks and projects.
Be a self-driven individual (1.) To be responsible for providing technical guidance / solutions (2.) To develop and guide the team members in enhancing their technical capabilities and increasing productivity (3.) TO ensure process compliance in the assigned module| and participate in technical discussions/review. (4.) To prepare and submit status reports for minimizing exposure and risks on the project or closure of escalations.
HCL Technologies Ltd.