PMS-IVDR Specialist (Laboratory Diagnostics)- Quality Engineer

HCL Technologies

  • Bangalore, Karnataka
  • Permanent
  • Full-time
  • 4 months ago
This rol is responsible for facilitating the efficient execution of all assigned Quality Compliance project activities and will support the Commercial Product Quality (CPQ) executing LD Post Market Surveillance Procedures.

Responsibilities Create, Review, Quality Technical Documentation related to IVDR Post Market Surveillance Plans, Post Market Surveillance Reports, Post Market Performance Follow Up Plans, Post Market Performance Follow Up Reports, Periodic Safety Update Reports and associated documentation. Track project performance, specifically to analyze the successful completion of short- and long-term goals Performs project/program management activities (defining scheduling, risk, change and opportunity and resources activities). Support the CPQ Post Market Surveillance Lead to ensure schedule compliance. Support the CPQ Post Market Surveillance Lead to ensure schedule compliance. Supports other CPQ Regulatory Reporting groups activities related to Field Actions, Adverse Events, Complaints and other activities assigned. Participates in technical review of Project related processes and documentation. Independently performs important areas of standard professional level work that typically requires processing and interpreting more complex, less clearly-defined issues. Schedules and may lead meetings to coordinate cross functional project activities required to resolve project issues. Supports project communications to all stakeholders including meeting minutes, monthly updates and other communications. Monitor status of each Post Market Surveillance Team deliverable; follow up effectively on each deliverable to ensure compliance to schedule and applicable customer procedures and regulations. Supports and participates in external partners relationships where required. Report to Post Market Surveillance Lead any discrepancies or issues that would place the project at risk. Create tools to manage efficiently assigned Projects. Support in updating / creating procedures. Support in trending and reporting requirements as they relate to Adverse Events and Field Actions. Serve as a backup for Complaint Searches in the Complaint Database. Create Customer Lists to Support the Field Action Process. May be assigned to other Commercial Product Quality activities. Write professional reports and presentations for reporting to management. Ensure documents are complete and in compliance with customer procedures and regulatory requirements. Responsible to collaborate effectively with other functions supporting Post Market Surveillance activities. May assist in literature reviews for IVDR Post Market Support activities. Requirements / Education: 6-8 years of experience with Medical Device Regulation (US and Outside of the US). Knowledge of IVDR Regulation highly desirable. BS/BA in related discipline (Biomedical/Biotech), or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas. Excellent Technical writing, communication and organizational skills necessary