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Quality Complaints Handling Management Specialist - Urgent Need

Company

MillenniumSoft Inc
Address San Antonio, TX, United States
Employment type CONTRACTOR
Salary
Category IT Services and IT Consulting
Expires 2023-08-08
Posted at 10 months ago
Job Description
Position : Quality Complaints Handling Management Specialist


Location : San Antonio, TX


Duration : 12 Months


Total Hours/week : 40.00


1stShift


Client: Medical Device Company


Job Category: Healthcare


Level Of Experience: Mid-Level


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


Workdays/hours: M - F 8am - 5pm local time



Primary Responsibilities and Duties


  • Routing the complaint to appropriate location for further evaluation.
  • Provide training to personnel involved in overall complaint process as directed by management.
  • Checking for complaint accuracy and content, correct information to process the complaint
  • Remain current in product knowledge and any upgrades to complaint handling systems.
  • Maintain expert knowledge level of the compliant handling system
  • Participates in all training classes including but not limited to, product training, regulatory training, compliance training and any testing involved.
  • Provide feedback to management for compliant process improvement opportunities (e.g., complaints systems, final letters, escalations process, etc...)
  • Review of complaint prior to closure for accuracy and appropriateness of the letter content as well as follow up acknowledgement notice, if required.
  • Maintain customer relations via multiple means, written, verbal, phone call’s… etc.
  • Maintains annually competencies through training and documentation of training.
  • Contact customers as needed to provide updates to outstanding quality issues.
  • Contact the customer or vendor for further information or follow up.
  • Perform history check on previously submitted complaints by customer to ensure that the customer is receiving an appropriate closing response.
  • Sample routing when applicable, to the investigation site
  • Ensure that the customer compliant complies with all relevant procedures
  • May perform other duties as required
  • Triage customer escalations and escalate to the Business units for response and resolution as needed
  • Create and review closing letters for accuracy and to ensure right the first-time approach to customer communications.
  • Acknowledgement to the customer of receipt and status of the complaint if needed.
  • Raise any escalated customer concerns to the next level of management.
  • Demonstrate technical competencies in mechanical, clinical, and functional in relation to all client products and areas.
  • 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.
  • Entering of the complaint into the complaint handling system
  • Provide training to peers as requested by management.
  • Interact with Health Care Workers, consumers, public and other professionals regarding their Quality concerns.


KSA Requirements (Knowledge, Skills, And Abilities)


  • Expert level knowledge of the Complaints handling system
  • Must be motivated, self-directed, and able to work with minimal supervision.
  • Excellent written and verbal communication skills
  • Proven ability to maintain a professional demeanor when handling complex user issues and high-pressure situations
  • Strong interpersonal skills
  • General knowledge of producing metrics and building reports.
  • Strong Project management skills
  • Excellent time management and multitasking skills
  • Demonstrated aptitude for identifying creative solutions to complex customer issues’ ability to“think outside the box”
  • Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803& 820, ISO 13485, and Canadian Regulations
  • Ability to take ownership and think independently, with minimal supervision
  • Proven ability to multi-task and seamlessly move between business unit platforms.
  • Must be able to communicate precisely and accurately to all levels of the organization
  • Strong personal commitment to quality, customer service and patient safety
  • Works well in a team environment
  • Strong analytical, deductive reasoning and listening skills
  • Ability to work with customers, system administrators, and clinicians
  • Business and computer skills


Education/Degree


  • Education/Degree: Life Science, Nursing, Medical Clinical Scientific or another relevant field.
  • Minimum 2+ years of experience in the complaint handling, medical device industry, customer relations, complaint trending, FDA/ISO regulations.
  • 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 client products