Project Manager

Bachelor's degree in a related field (e.g., Mechanical Engineering, Bio Medical)

8-10 years of work and project management experience,

Leading or supporting the execution of Small to large-scale sustenance engineering projects like FCO (Field Change Orders) projects

Strong Knowledge on ISO 13485, ISO 14971 and FDA- 21CFR 7, 21CFR 810 & 21CFR 806

Ensures to comply with QSR, ISO and Environment, HS requirements, as well as all applicable company procedures and policies

Interacts and collaborates with other departments to solve any restriction that may stop or slow down process issues.

Cross-Functional Collaboration: Facilitate cross-functional collaboration for remediation plan implementation, task assignment, and deadline management.

Project Coordination: Facilitate and coordinate medical device recall projects, ensuring compliance with regulatory standards and adherence to critical timelines

Risk Mitigation: Manage risk mitigation efforts for medical device recalls, enhancing patient safety through strategic oversight and account management.

Risk Assessments and Documentation: Conduct risk assessments, strategize effective solutions, and maintain detailed project documentation to support regulatory compliance and project efficiency.

Customer Support: Provide customer support to stakeholders, addressing inquiries and ensuring effective communication.

creating and promoting strategies to increase the quality and efficiency of systems and products Process awareness from project initiation to closure.

Project Management documentation like Business cases, Project charters, Project Schedules-Project management excellence is critical for success.

Communication and soft skills, building connections, running local & global CFT teams, persistence, logical thinking, problem solving.

Determine action items, Track, make necessary follow ups and resolve challenges and make project progress