Complaint Handling Specialist - Urgent Need
Company: millenniumsoft
Location: San Antonio
Posted on: April 1, 2026
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Job Description:
Position : Complaint Handling Management Specialist Location :
San Antonio, TX Duration : 12 Months Total Hours/week : 40.00 1st
Shift Client: Medical Device Company Job Category: Customer Service
Level Of Experience: Entry Level Employment Type: Contract on W2
(Need US Citizens or GC Holders Only) 3 must haves: Customer
Service Skills; Complaint Handling Skills; Medical Device
Experience a plus! Hours are 8a to 5p CST - Monday through Friday.
Job Description: Primary Responsibilities and Duties Medical Device
Product Complaint Handling Medical Device Reporting (FDA) Manage
intake and reporting of the product complaint handling process
including, receipt of complaints from all sources (including
Service Cases and Work Orders) and all in process steps complaint
determination, Data entry, Critical Thinking to request additional
information (as needed), reportability decisions, MDR filing, and
serve as point of contact for customer communication. Routing the
complaint to appropriate location for further evaluation. Entering
of the complaint into the complaint handling system Checking for
complaint accuracy and content, correct information to process the
complaint Provide training to personnel involved in overall
complaint process as directed by management. Participates in all
training classes including but not limited to, product training,
regulatory training, compliance training and any testing involved.
Maintains annually competencies through training and documentation
of training. Contact the customer or vendor for further information
or follow up. Acknowledgement to the customer of receipt and status
of the complaint if needed. Sample routing when applicable, to the
investigation site Interact with Health Care Workers, consumers,
public and other professionals regarding their Quality concerns.
Maintain customer relations via multiple means, written, verbal,
phone call’s… etc. Answering of Inbound/Outbound Calls. Contact
customers as needed to provide updates to outstanding quality
issues via phone/email. Review of complaint prior to closure for
accuracy and appropriateness of the letter content as well as
follow up acknowledgement notice, if required. Triage customer
escalations and escalate to the Business units for response and
resolution as needed Perform history check on previously submitted
complaints by customer to ensure that the customer is receiving an
appropriate closing response. Ensure that the customer compliant
complies with all relevant procedures Demonstrate technical
competencies in mechanical, clinical, and functional in relation to
all client products and areas. Remain current in product knowledge
and any upgrades to complaint handling systems. Create and review
closing letters for accuracy and to ensure right the first-time
approach to customer communications. Maintain expert knowledge
level of the compliant handling system Provide feedback to
management for compliant process improvement opportunities (e.g.,
complaints systems, final letters, escalations process, etc)
Provide training to peers as requested by management. Raise any
escalated customer concerns to the next level of management. May
perform other duties as required KSA Requirements (Knowledge,
Skills, and Abilities) Comprehensive knowledge of Quality System
standards and regulations including 21 CFR 803 & 820, ISO 13485,
and Canadian Regulations Ability to work with customers, system
administrators, and clinicians Proven ability to maintain a
professional demeanor when handling complex user issues and
high-pressure situations Expert level knowledge of the Complaints
handling system Proven ability to multi-task and seamlessly move
between business unit platforms. Ability to take ownership and
think independently, with minimal supervision General knowledge of
producing metrics and building reports. Strong analytical,
deductive reasoning and listening skills Must be able to
communicate precisely and accurately to all levels of the
organization Strong interpersonal skills Strong Project management
skills Demonstrated aptitude for identifying creative solutions to
complex customer issues’ ability to “think outside the box”
Excellent time management and multitasking skills Excellent written
and verbal communication skills Works well in a team environment
Strong personal commitment to quality, customer service and patient
safety Business and computer skills Must be motivated,
self-directed, and able to work with minimal supervision.
Education/Degree: Life Science, Nursing, Medical Clinical
Scientific or another relevant field. In lieu of degree:
Combination of Educations and Experience is considered Experience
(in years) Minimum 1 years of experience with medical terminology,
Nursing, Clinical or laboratory knowledge and familiarity with BD
products Minimum 2 years of experience in the complaint handling,
medical device industry, customer relations, complaint trending,
FDA/ISO regulations.
Keywords: millenniumsoft, San Antonio , Complaint Handling Specialist - Urgent Need, Customer Service & Call Center , San Antonio, Texas
