The Complaint Investigator is responsible for conducting investigations on 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 Investigator identifies causes of complaints, documents the findings, and escalates issues in accordance with company policy.
Essential Functions and Main Duties
- Responsible for processing complaints while using good documentation practices (GDP).
- Interface with Customer Service, Field team, and customers to gather additional information required for complaint initiation/investigations.
- Interacts with customers verbally or in writing using clear, effective communication.
- Conduct investigations and provide data to drive corrective and preventive actions and complaints based on sound engineering analysis and review.
- Manage and assess incoming complaints and elevate potential issues/incidents to Quality Management/supervisor, including but not limited to, possible recall situations, remedial action, and field safety actions.
- Review compliant files for completeness and follow-up with suppliers (responsible party) as applicable for investigation outcomes.
- Work closely with Manufacturing, Operations, R&D and other departments to ensure quality products and processes are developed, deployed, and meets US and OUS requirements. This includes hardware and software validation, risk analysis/FMEA, etc.
- Utilize systems for the identification, analysis, correction, and prevention of quality issues.
- Conduct and maintain complete complaint files and databases for all customer complaints per US engineering activities in compliance with FDA Regulations, ISO 13485 and other national and international quality and regulatory (as applicable) requirements and company procedures standards.
- Prepare customer notification letters for receipt of product complaint and follow-up acknowledgement letters information, as required.
- Utilizes product and incident complaint codes to conduct data trending and analysis review.
- Lead complaint investigation to understand root cause in support of documenting proper complaint file closure.
- Complete all required customer complaint related documentation in an accurate, professional, and timely manner.
- Perform queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints.
- Provide follow-up to internal and external customers needed, including customer correspondence and regulatory agency correspondence.
- Prepare final correspondence summarizing investigation findings.
- Create/gather, analyze, and provide feedback on complaint data for the team and management for post market surveillance activities, and participate in projects as required.
- Assist as needed in the preparation of data for internal audits and external audits/inspections
- 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:
Competencies Required:
- Must be able to demonstrate ability to understand the medical device product and its application.
- 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 or equivalent.
- Proficient computer skills and knowledge of relevant business applications, Microsoft Office applications. Ability to learn other software quickly as required.
- Must be detail oriented.
- Decision making is required in balancing priorities amongst other ongoing tasks and being responsive to critical situations.
- Critical thinking and strong problem-solving skills
- Effective verbal and interpersonal skills
- Demonstrates good judgement in selecting methods and techniques for obtaining solutions.
- Role model for other team members.
- Strong knowledge of the product and investigation requirements.
- Assists other levels with building up their technical capabilities.
- 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 $38.00 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 [email protected].
