Bindu Siri

Adaptable and innovative Engineering professional with extensive experience in Quality Assurance and Quality System Management including CAPA, Risk Management, Complaint Investigations, Vigilance reporting. Strong understanding of ISO 13485, FDA 21 CFR Part 820 and risk management (ISO 14971). Skilled in driving product quality initiatives, ensuring regulatory compliance, and leading cross-functional teams to achieve organizational goals.

Seeking to leverage expertise in Quality Assurance and Project Management within a forward-thinking company that values key participation, team-oriented collaboration, immediate challenges, and long-term career growth opportunities.

Post Market Surveillance – Medical Devices - L & T Technology Services

(2021-10)

• Evaluated incoming data and determine if it is sufficient to understand the nature of the complaint.
• Evaluated customer feedback, service records, and other sources of customer and internal records to identify potential complaints.
• Communicated with customers and Field Service Engineers to gather more data on complaints as needed. Collaborated with Engineers, Clinical Specialists, Field Service Engineers and Application Specialists, and Manufacturing personnel to facilitate the complaint handling process globally.
• Analyzed complaints to determine reporting eligibility and completes initial assessment. To determine complaint risk and investigation level based on reportability decisions made.
• Responsible for evaluating whether complaints were reportable to regulatory authorities by completing the applicable decision trees. (i.e. European, Canadian, Brazilian, Australian, and/or Chinese).
• Evaluated adverse events and product quality complaints and conducts complaint investigation in accordance with operating procedures using the product quality management systems.
• Responsible for the overall processing of adverse event information in compliance with applicable FDA and global regulations and Standard Operating Procedures (SOPs) and guidelines.
• Performed technical file remediation to ensure compliance to EU MDR requirements.
• Creates summaries of the investigation, including the corrective action and preventive action (CAPA).
• Responsible for maintaining the quality processes associated with regulatory reporting and its procedures or controls to ensure that all MDR reportable complaints are processed and submitted in accordance with established company procedures and worldwide regulations and standards.
• Responsible for processing complaint files globally from Intake status to closure; including coding for USA, EU, China, Japan, Latin America, Australia and close files appropriately within 60 to 90 days to meet metrics.
• Responsible for the customer complaints regulatory reporting process (timely submissions, timely closure, health authority requests).
• Coordinated actions related to product and quality system deficiencies, including issuing relevant notifications to regulatory authorities.
• Processed serious product complaints according to internal confidential operating procedures. Performs complaint case review, malfunction coding, as applicable, investigation by manufacturing site and escalation, as appropriate.
• Prepared customer letters by providing the outcome of the investigation to servicing personnel and healthcare professionals.
• Good understanding on root cause analysis for complaint investigation using Ishikawa diagram (fishbone cause and effect).
• Evaluated all information from a clinical and technical perspective to ensure appropriate Analysis, Investigation, Root Cause, and Quality Engineering review is documented prior to complaint closure.
• Contributed to the achievement of team performance metrics and organizational goals.
• Supported in the training and qualification of new staff to ensure compliance with organizational standards and role requirements.
• Ensured continuous monitoring of quality and key performance indicators (KPIs), driving performance to target levels while upholding uncompromised quality standards.

Master of Technology - Biomedical Signal Processing and Instrumentation - JSS Science and Technology University, Karnataka

Bachelor of Engineering - Electronics and Communication Engineering - Visvesvaraya Technological University, Karnataka