Siva Sai Kovi
Hyderabad
Summary
Highly skilled and motivated Sr Quality Analyst with 7.5 years of experience in Complaints Handling activities related to MDR products and handling different types of Complaints. As a Complaint Handling Specialist – Analyzing and reviewing complaints as per product malfunction and failure analysis for various Medical Devices. Knowledge on FDA 21 CFR Parts 803, 806 & 820 and ISO 13485. Strong problem-solving abilities and a proven track record of delivering high-quality solutions. Excellent communication and collaboration skills, ensuring seamless coordination within cross- functional teams. Dedicated to staying up-to-date with emerging technologies and industry best practices. Recognized for excellence in teamwork and continuous improvement, significantly reducing MDR backlogs. Skilled in Smart Solve and SAP, with a flair for leading teams towards achieving stringent quality standards.
Overview
8
8
years of professional experience
Work History
Sr Quality Engineer
Saraca Solutions
Hyderabad
07.2024 - Current
- Processing various types of customer complaints end-to-end
- Analyze and process Diabetes product complaints into database received from both solicited sources (post marketing studies, NPD studies, clinical trials) and unsolicited sources (legal, social media, literature) as per 21CFR 820.198(a)
- Identifying and making the complaint whether reportable or not reportable based on the scenario’s mentioned in service records, based on failed pre-tests, based on repair activity codes and Technician notes
- Providing the investigation summary based on pre-tests that failed during the servicing of a product, including the service activity code and notes provided by the technicians.
- Write investigation summaries based on technical product analysis information provided
- Performs follow up activities to obtain additional information
- Determine Reportability of complaints to Government Agencies
- Preparing MedWatch report due date metrics and timelines according to country health authorities
- Identify and document appropriate complaint categories to assure trend accuracy within the complaint database
- Assisting with CAPA investigations and identifying the root cause
- Part of Remediation for software products to find the gap assessment
- Worked closely with quality assurance and regulatory affairs teams to determine the root cause of the complaint and to gather necessary information for investigation
- Provided technical guidance and support to other team members when needed
- Participated in internal audits and provided constructive feedback to improve quality
- Responsible for complaints handling KPI’s
- Preparing various reports as per post-market requirements.
- Hands on experience on Risk Management, provided support when required
- Recognized for initiating, identifying process gaps, and initiating various process improvements in preventing late MDRs.
- AWARDS and ACHIEVEMENTS:
- Received Best Team player award for Bringing Down the backlog
- Awarded as star of the Quarter for being a multi-tasker
Sr Associate
Cognizant Technolgy Solutions
Hyderabad
03.2022 - 05.2024
- Evaluating complaints from patient safety perspective and identify complaints that require further evaluation under 21CFR part 803 (MDR)
- Analyze data on patient safety and risk, ensuring compliance with applicable post market regulations
- Identifying the hazardous and evaluating those complaints based on Risk Assessment document
- Documenting the new Risk Scenario’s in Risk Assessment document based on the Complaints
- Providing the investigation summary based on pre-tests failed during servicing of a product, service activity code and notes provided the technicians
- Reporting the reportable complaints to the respective countries Health Authorities within the Timeliness
- Assess reportability and prepare MDR/regulatory submissions according to country health authority requirements.
- Conduct walkthrough on complaint handling process as a part of SME and co-ordinate query meetings
- AWARDS and ACHIEVEMENTS:
- Received Silver Award for best performance of the year
- Received POB award for quality of the work
Sr Associate
Tech Mahindra pvt ltd
Hyderabad
04.2018 - 03.2022
- Entering (intake) complaints based on different types of communications, such as Synergy forms, service records, mail communications, etc., investigating, and closing the complaints.
- Providing the investigation summary based on pre-tests failed during servicing of a product, service activity code and notes provided by the technicians.
- Identifying and making the complaint whether reportable or not reportable based on the scenario’s mentioned in-service records, based on failed pre-tests, based on repair activity codes and Technician notes.
- Reporting the reportable complaints to the respective countries' health authorities within the timeliness.
- Preparing MedWatch report due date metrics and timelines according to country health authorities.
- Preparing various follow up activity reports like product return follow up, customer follow up, service center follow-ups.
- Hands-on experience in retrieving manufacturing details of products through the SAP database.
- Ensure to produce the quality data to the client with high efficiency.
- AWARDS and ACHIEVEMENTS:
- Received Star of the month Award for Process Improvements and for designing the work flow.
Associate
Apex
Hyderabad
03.2017 - 03.2018
- The goal of the Reference Process project is to clean and parse citations in support of their Web Science database.
- A citation or bibliographic citation is a reference to a book, article, web page, or other published item, with sufficient detail to identify the item uniquely.
- Different citation systems and styles are used in scientific citation, legal citation, prior art, and the humanities.
- Parameters involved in a citation are Author, Volume, Page, Year, Title and Article Identifier.
- Ensure that you produce quality data for the client with high efficiency.
- AWARDS and ACHIEVEMENTS:
- Received Best Team player award for Bringing Down the backlog
Education
Bachelor - Mechanical Engineering
Bharath University
Chennai04-2015
Skills
- Complaint Handling - Medical Devices
- Complaints Handling software's: Smart Solve, SAP
- Effective Communication
- Interpersonal Skill
- Teamwork & collaboration
- Analytical Skill
- Creative & Critical Thinking
- Problem Solving
- Decision Making
- Project management
- Time management
- Flexibility
- Adaptability
- Excel
- Word
- PPT
- Quality
- Continuous Improvement
- Team Leadership
Hobbies and Interests
- Playing Badminton and Cricket
- Surfing Internet and Social Media
Languages
Telugu
First Language
English
Proficient (C2)
C2
Tamil
Proficient (C2)
C2
Timeline
Sr Quality Engineer
Saraca Solutions
07.2024 - Current
Sr Associate
Cognizant Technolgy Solutions
03.2022 - 05.2024
Sr Associate
Tech Mahindra pvt ltd
04.2018 - 03.2022
Associate
Apex
03.2017 - 03.2018
Bachelor - Mechanical Engineering
Bharath University
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