Senior Quality Complaints Investigator I

Summary

The Senior Quality Complaints Investigator I is responsible for performing and aiding in complaints investigations as well as product performance, complaint reporting to regulatory agencies and trend analysis activities.

Responsibilities

• Maintain complete and accurate complaint records. Evaluate the potential risks associated with customer complaints and prioritize investigations accordingly. Able to identify patterns to proactively address potential product issues.
• Conduct initial investigations to determine the nature and severity of complaints. Assists with drafting and filing adverse event reports with RA authorities
• Lead and oversee complex complaint investigations, including those related to serious incidents and potential recalls
• Coordinate and conduct thorough investigations, including managing the systems in place to track previous investigations and basic analysis of complaint trends. Drive improvement initiatives to enhance complaint handling process
• Collaborate with product development and manufacturing teams to assess product design, manufacturing processes, and quality control
• Meets all adverse reporting timelines in accordance with applicable country regulations
• Assist with product launch support and provides in depth knowledge of procedures and processes to the cross functional teams regarding PMS requirements and expectations.
• Develops and leads training to other associates pertaining to complaint management, documentation in SFDC / SAP and product performance issues.
• Assists with development and updates of SOPs related to complaint handling.
• Provides support during internal and external audits
• In depth understanding of applicable regulations and guidelines governing post-market surveillance activities, such as medical device regulations (e.g., FDA's 21 CFR Part 820, 803, 806, ISO 13485, EU / MDR, etc.) and consumer product safety regulations.

Essential Functions of the Role

Work Experience Requirements

Experience in the medical device industry is highly preferred in the areas of data analysis, complaints, CAPA

Education Requirements

Specialized Skills / Technical Knowledge

Mode - Hybrid

Location - Gurugram

Skills Required

Iso 14971, Sap, Iso 13485, Sfdc, MDR, Microsoft Office Suite