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:

• 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