Senior Quality Investigator I-II

Job description

We Make Life More Rewarding and Dignified Location : ​Libertyville​: Department : ​Regulatory 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. Hollister Incorporated operates in a hybrid work environment. Employees are expected to come into the office a minimum of 4 days per week. Sponsorship to work in the US is not available at this time. Responsibilities: 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, EUMDR, etc.) and consumer product safety regulations. - 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 o...