Job Openings >> Complaints Management Specialist -Urgent Need 
Complaints Management Specialist -Urgent Need 
Summary
Title:Complaints Management Specialist -Urgent Need 
ID:4096483
Department:Development
Description

Position : Complaints Management Specialist -Urgent Need 

Location : San Antonio, TX

Duration : 12 Months

Total Hours/week : 40.00

1st Shift

Client: Medical Device Company

Job Category: Healthcare

Level Of Experience: Mid-Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

 

Job Description:

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

 

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:

  • (e.g., BA or BSc degree in (major) or (#) yrs. relative experience in lieu of a degree) 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.

 

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