Senior Quality Complaints Investigator I

1 day ago

Gurgaon, Haryana, India Hollister US Full time ₹ 12,00,000 - ₹ 24,00,000 per year


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**:

  • Very little physical effort required to perform normal job duties (unless otherwise indicated)
  • Must have manual dexterity (use of mouse, keyboard), to type and enter data in the computer as well for preparing presentations
  • Travel 10%


Work Experience Requirements

  • 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

  • Bachelor's degree in science, engineering, clinical
  • Experience with ISO 13485, 21 CFR 820, MDD / MDR, ISO 14971


Specialized Skills/Technical Knowledge:

  • Strong interpersonal and decision making skills
  • Strong analytical and problem-solving skills
  • Must have strong organizational and time management skills
  • Possess the ability to work under pressure and exhibit multi-tasking capabilities
  • Requires strong understanding of global regulatory requirements for PMS.
  • Understands medical terminology.
  • Ability to interpret and communicate complex clinical information to diverse stakeholders
  • Must have manual dexterity (use of mouse, keyboard) – to type and enter data into a computer
  • Must be able to sit for prolonged periods of time (6-8 hours per day)
  • Must be able to stand for significant periods of time (3-4 hours per day)
  • Must be able to handle multiple prolonged telephone conversations
  • Ability to travel and perform customer visits
  • Experience with Microsoft Office suite


Mode - Hybrid

Location - Gurugram

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