The Complaint Handler is responsible for receiving, reviewing, and processing all product complaints for company manufactured and distributed products as required by applicable regulations, standards, and company policy. This position will interface with cross-functional groups such as customer service, technical support, field personnel, operations, and others for the identification and resolution of customer complaints and may interact directly with customers. The Complaint Handler evaluates each complaint and ensures the proper and timely handling, including evaluation of any potential patient or user injury complaints and properly escalates the issue in accordance with company policy.

Essential Functions and Main Duties

• Responsible for processing quality complaints while using good documentation practices (GDP).
• Interface with Customer Service, Field team, and customers to gather additional information required for complaint initiation/investigations.
• Occasionally interacts with customers verbally or in writing using clear, effective communication.
• Responsible for complaint handling process from initiation to MDR & Incident Reporting, to file closure in a uniform and timely manner.
• Maintain complete complaint files and databases for all customer complaints in compliance with FDA Regulations, ISO 13485 and other national and international quality and regulatory (as applicable) requirements and company procedures standards.
• Reviews complaint records in accordance with procedures to confirm complaint, determines reportability (US MDR) in a uniform and timely manner.
• Prepare MedWatch reports and OUS incident reports (as applicable) for review and finalize reports for submission to applicable regulatory agencies.
• Assist as needed in the preparation of records for internal audits and external audits/inspections.
• Generate reports to monitor assigned complaints, regulatory submissions, and follow-up actions.
• Complaint Trending.
• Adhere to all company policies, procedures, and business ethics codes.
• Duties may be modified or assigned at any time based on business need.

Qualifications

Education / Certification / Experience Required:

• Bachelor's degree in business, communications or related discipline.
• 2+ years of experience with complaint handling and evaluating complaints for MDR (Medical Device Reporting); or equivalent work experience.
• Experience with SAP or similar systems for complaint tracking and product data.
• Level and compensation depend on location, experience, education and skills.

Competencies Required:

• Must be able to demonstrate ability to understand the medical device product and its application.
• Must be able to apply FDA Medical Device Reporting and Quality System Regulation (21 CFR Part 803, 806, and 820) and ISO Standards (ISO 13485-QMS), as they relate to complaint processing and adverse event reporting.
• Proficient computer skills and knowledge of relevant business applications, including Microsoft Office applications.
• Experience with Complaint Handling software.
• Effective verbal and written communication skills and ability to work with all individuals in a professional and cooperative manner.
• Works on problems of a diverse scope to assist in finding a resolution.
• Demonstrates good judgement in selecting methods and techniques for obtaining solutions.
• Must be detail oriented.
• Must be able to communicate verbally and in writing, and to receive and understand verbal and written instructions in English.
• Able to work effectively both independently and in a collaborative team environment.

Compensation

The anticipated range for this position is an hourly rate of $24.00 to $35.00 Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, experience and location.

Perks and Benefits

Visit our Career page to learn more about Perks & Benefits and working at Nihon Kohden America.

Working Conditions

Schedule: The regular hours for this full-time position are 8:00 a.m. to 5:00 p.m., Monday-Friday, unless otherwise stated by the department manager. Holiday, weekend, and evening work hours may be required. Regular hours may vary due to the needs of the organization or department and are subject to change at any time at the Company's discretion.

Physical: Generally, may require some reaching, bending, stooping, squatting, crawling, kneeling, pushing, pulling, lifting, carrying up to 20 pounds, finger dexterity, repetitive motions, standing, walking, sitting, hearing, visual acuity, and color vision. More specific details may be provided as needed or requested.

Travel: Minimal

Access To Customer Sites: Not Required

Nihon Kohden America is committed to maintaining a professional and respectful workplace free from discrimination, harassment, and retaliation and welcomes all qualified candidates to apply. Employment decisions are based on qualifications, experience, and business needs, without regard to legally protected characteristics. This policy applies to all employment actions, including recruitment, hiring, promotion, compensation, training, and other workplace practices.

Nihon Kohden America complies with all applicable federal, state, and local laws regarding equal employment opportunity. Employees and applicants will not be subject to harassment or retaliation for asserting their legal rights. Questions or concerns regarding this policy may be directed to Human Resources at HREmployeeServices@nihonkohden.com.