Senior Quality Investigator I-II

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.

• 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, EUMDR, etc.) and consumer product safety regulations.

Experience in the medical device industry is highly preferred in the areas of data analysis, complaints, CAPA

• Registered Nurse preferred
• Experience with ISO 13485, 21 CFR 820, EU MDR, ISO 14971
• Strong interpersonal and decision making skills
• Strong analytical and problem-solving skills
• Must have strong organizational and time management skills
• Experience using complaint systems
• 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