Description

The Product Complaints Analyst II under general supervision, handles timely input of product complaints into the complaint database, including investigating complex complaints in a compliant manner, and determining if products are performing within specifications by completing a variety of tasks.
Responsibilities

• Review product documentation, track and trending data, submitting data, and/or consulting with third parties.
• Maintain compliant and detailed complaint records.
• Process customer complaints within specified timelines in accordance with US and international regulatory requirements and company policies.
• Responsible for ensuring all required information for a complaint file is obtained and properly documented to make sound regulatory reporting decisions and submissions for Medical Device Reporting (MDR), 21 CFR 803.
• Evaluate all information from a clinical and technical perspective to ensure appropriate analysis, investigation, root cause, and quality engineering review is documented prior to complaint closure.
• Write customer response letters, as required.
• Assist in FDA and Notified Bodies Inspections.
• Attend and/or set up meetings and effectively communication with complain groups as well as other internal departments such as Engineering, Marketing, R&D, Customer Service, and Technical Services.
• Establish reports for the prompt review of new complaints, regulatory reporting, decisions, and follow-up.
• Possess a thorough understanding of the complaint database.
• Escalate trends and product problems for disposition as necessary.
• May receive technical guidance on complex problems, but independently determines and develops approaches and solutions.
• Ensure compliance with the company’s Quality System policies and procedures, and applicable standards as pertains to medical devices.
• May be responsible for training other staff members.
• Other duties as assigned.

For United States Applicants Only:
Inari Medical E-Verify Poster (English and Spanish)
Inari Medical Right to Work Poster (English)
Inari Medical Right to Work Poster (Spanish)