Complaint Handler 1
Company: Nihon Kohden
Location: Irvine
Posted on: August 7, 2022
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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
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