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:
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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.
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Conduct initial investigations to determine the nature and severity of complaints. Assists with drafting and filing adverse event reports with RA authorities
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Lead and oversee complex complaint investigations, including those related to serious incidents and potential recalls
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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
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Collaborate with product development and manufacturing teams to assess product design, manufacturing processes, and quality control
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Meets all adverse reporting timelines in accordance with applicable country regulations
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Assist with product launch support and provides in depth knowledge of procedures and processes to the cross functional teams regarding PMS requirements and expectations.
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Develops and leads training to other associates pertaining to complaint management, documentation in SFDC/SAP and product performance issues.
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Assists with development and updates of SOPs related to complaint handling.
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Provides support during internal and external audits
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In depth understanding of applicable regulations and guidelines governing post:market surveillance activities, such as medical device regulations (e.g., FDAs 21 CFR Part 820, 803, 806, ISO 13485, EU/MDR, etc.) and consumer product safety regulations.
Essential Functions of the Role:
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Very little physical effort required to perform normal job duties (unless otherwise indicated)
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Must have manual dexterity (use of mouse, keyboard), to type and enter data in the computer as well for preparing presentations
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Travel 10
Work Experience Requirements
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Number of Overall Years Necessary: 5:8
Experience in the medical device industry is highly preferred in the areas of data analysis, complaints, CAPA
Education Requirements
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Bachelors degree in science, engineering, clinical
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Experience with ISO 13485, 21 CFR 820, MDD / MDR, ISO 14971
Specialized Skills/Technical Knowledge:
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Strong interpersonal and decision making skills
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Strong analytical and problem:solving skills
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Must have strong organizational and time management skills
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Possess the ability to work under pressure and exhibit multi:tasking capabilities
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Requires strong understanding of global regulatory requirements for PMS.
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Understands medical terminology.
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Ability to interpret and communicate complex clinical information to diverse stakeholders
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Must have manual dexterity (use of mouse, keyboard) : to type and enter data into a computer
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Must be able to sit for prolonged periods of time (6:8 hours per day)
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Must be able to stand for significant periods of time (3:4 hours per day)
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Must be able to handle multiple prolonged telephone conversations
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Ability to travel and perform customer visits
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Experience with Microsoft Office suite
Mode : Hybrid
Location : Gurugram

Job Type: Permanent