Complaint Investigator

About the role

The Complaint Investigator conducts investigations on product complaints for company-manufactured and distributed products as required by applicable regulations, standards, and company policy. This position interfaces with cross-functional groups such as customer service, technical support, field personnel, operations, and others to identify and resolve customer complaints. The role may involve direct customer interaction and requires identifying causes of complaints, documenting findings, and escalating issues according to company policy.

Responsibilities

• Process complaints using good documentation practices (GDP).
• Interface with Customer Service, Field teams, and customers to gather additional information for complaint initiation and investigations.
• Communicate with customers verbally or in writing using clear, effective communication.
• Conduct investigations and provide data to drive corrective and preventive actions based on sound engineering analysis.
• Manage and assess incoming complaints, elevating potential issues to Quality Management or supervisors, including possible recall situations or field safety actions.
• Review complaint files for completeness and follow up with suppliers for investigation outcomes.
• Collaborate with Manufacturing, Operations, R&D, and other departments to ensure quality products and processes meet U.S. and international requirements, including hardware and software validation, risk analysis, and FMEA.
• Utilize systems for identifying, analyzing, correcting, and preventing quality issues.
• Maintain complete complaint files and databases in compliance with FDA Regulations, ISO 13485, and other applicable standards.
• Prepare customer notification and follow-up letters as required.
• Conduct data trending and analysis using product and incident complaint codes.
• Lead complaint investigations to determine root causes and ensure proper file closure.
• Complete all required documentation accurately, professionally, and in a timely manner.
• Perform queries to provide complaint data and ad hoc trend analysis on reported product problems.
• Provide follow-up to internal and external customers, including correspondence with regulatory agencies.
• Prepare final correspondence summarizing investigation findings.
• Analyze and provide feedback on complaint data for post-market surveillance activities.
• Participate in projects and assist in preparing data for internal and external audits/inspections.
• Adhere to all company policies, procedures, and business ethics codes.
• Perform additional duties as assigned based on business needs.

Requirements

• Bachelor’s degree in science or a related discipline; relevant education and experience accepted in lieu of a degree.
• 1+ years of relevant or similar experience.

Skills

• Ability to understand medical device products and their applications.
• Preferred knowledge of FDA Medical Device Reporting and Quality System Regulation (21 CFR Part 803, 806, and 820) and ISO Standards (ISO 13485-QMS, ISO 14971-Risk Management) as they relate to complaint investigations.
• Proficient computer skills, including knowledge of Microsoft Office applications and the ability to learn new software quickly.
• Detail-oriented with strong critical thinking and problem-solving skills.
• Effective verbal and interpersonal communication skills.
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Strong knowledge of product and investigation requirements.
• Ability to communicate verbally and in writing in English and understand instructions.
• Ability to work effectively both independently and in a collaborative team environment.

Pay

The anticipated hourly range for this position is $24.00 to $38.00. Actual placement within the range depends on skills, education, experience, and location.

Benefits

Visit the company’s Career page to learn more about perks and benefits.

Schedule

This is a full-time position with regular hours from 8:00 a.m. to 5:00 p.m., Monday through Friday. Holiday, weekend, and evening work may be required as needed. Hours may vary based on organizational or departmental needs and are subject to change at the company’s discretion.

Working Conditions

• Physical: May require reaching, bending, stooping, squatting, crawling, kneeling, pushing, pulling, lifting, or carrying up to 20 pounds. Tasks may involve finger dexterity, repetitive motions, standing, walking, sitting, hearing, visual acuity, and color vision.
• Travel: Minimal.
• Access to customer sites: Not required.