Complaint Handler 1

Company: Nihon Kohden
Location: Irvine
Posted on: August 7, 2022

Job Description:

Job Description The Complaint Handler 1 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 1 evaluates each complaint and ensure the proper and timely handling, including evaluation of any potential patient or user injury complaints and properly escalate the issue in accordance with company policy. Target hourly rate is $20.00 or above, depending on years of experience and expertise. 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 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: Associates degree or relevant experience required. 1 years of administrative, data entry, or similar experience. 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. 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. Able to work effectively both independently and in a collaborative team environment 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, color vision, and 2-way written/verbal communication in English. More specific details may be provided as needed or requested. TRAVEL: Minimal ACCESS to CUSTOMER SITES: Not Required PERKS AND BENEFITS Click here to learn more about working at Nihon Kohden America Paid Time-Off Group Insurance Plans FSA, HSA 401(k) Company Bonus Vacation Donations Car Allowance Program Wellness Program Volunteer Day NK University Tuition Reimbursement Professional Development Discounted Tickets Employee Referral Bonus up to $4,000 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, color vision, and 2-way written/verbal communication in English. More specific details may be provided as needed or requested. TRAVEL: Minimal ACCESS to CUSTOMER SITES: Not Required Nihon Kohden America---s official EEO policy statement follows. In keeping with this policy, Nihon Kohden America will continue to recruit, hire, train, and promote into all job levels the most qualified persons without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, genetic information, disability, or because he or she is a protected veteran. Similarly, Nihon Kohden America will continue to administer all other personnel matters (such as compensation, benefits, transfers, layoffs, company-sponsored training, education, tuition assistance, and social and recreational programs) in accordance with Company policy. Nihon Kohden America bases employment decisions on objective standards as much as possible in the furtherance of equal employment opportunity.

Keywords: Nihon Kohden, Irvine , Complaint Handler 1, Professions , Irvine, California