Complaint Investigator at Nihon Kohden America in Irvine, CA

Summary: Nihon Kohden America is a company focused on manufacturing and distributing medical devices, and they are seeking a Complaint Investigator. The role involves conducting investigations on product complaints, interfacing with various departments to resolve customer issues, and ensuring compliance with regulatory standards.

Responsibilities:
- 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

Required Qualifications:
- Bachelor's degree in science or related discipline; relevant education and experience accepted in lieu of degree
- 1+ years relevant or similar experience
- Must be able to demonstrate ability to understand the medical device product and its application
- 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

Preferred Qualifications:
- 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

Required Skills: Medical device product knowledge, FDA Medical Device Reporting, Quality System Regulation 21 CFR Part 803, Quality System Regulation 806, Quality System Regulation 820, ISO 13485-QMS, ISO 14971-Risk Management, Documentation Practices (GDP), Microsoft Office, Complaint investigation, Root cause analysis, Risk analysis/FMEA, Data trending and analysis, Post market surveillance, Internal and external audit preparation, Effective verbal communication