Complaints Handling Management Specialist
Company: millenniumsoft
Location: San Antonio
Posted on: April 1, 2026
|
|
|
Job Description:
Complaints Handling Management Specialist Medical Devices
Company Position : Complaints Handling Management Specialist
Location : San Antonio, TX Duration : 12 Months Total Hours/week :
40.00 1st Shift Client: Medical Device Company Job Category:
Healthcare Level of Experience: Entry Level Employment Type:
Contract on W2 (Need US Citizens or GC Holders Only)
Workdays/hours: M - F 8am - 5pm Note: *Initial training onsite.
Potential for Hybrid once training is complete* Roles &
Responsibilities Primary Responsibilities and Duties Manage the
process of the complaint handling system including, receipt of
complaints from all sources (including Service Cases and Work
Orders) and all in process steps including data entry. 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. Contact customers as needed to provide updates
to outstanding quality issues. 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 Experience Required Experience (in
years) Minimum 1 years of experience with medical terminology,
Nursing, Clinical or laboratory knowledge and familiarity with
client products Minimum 2 years of experience in the complaint
handling, medical device industry, customer relations, complaint
trending, FDA/ISO regulations. Skills & Certifications 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.
Eligibilities & qualifications Education/Degree: AS degree in
nursing, Scientific or other relevant field.
Keywords: millenniumsoft, Round Rock , Complaints Handling Management Specialist, Customer Service & Call Center , San Antonio, Texas