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Complaint Management

Company: Integrated Resources, Inc
Location: Sandy
Posted on: June 12, 2021

Job Description:

Job Title: Complaint Management
Duration: 12+ Months (Possible Extension)
Location: Sandy, UT 84070


  • 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 calls... 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 personal commitment to quality, customer service and patient safety
  • Business and computer skills
Education & Experience:
  • Education/Degree: (e.g., BA or BSc degree in (major) or (#) yrs. relative experience in lieu of a degree)
  • Minimum 1+ years of experience with medical terminology, Nursing, Clinical or laboratory knowledge and familiarity with products
  • Minimum 2+ years of experience in the complaint handling, medical device industry, customer relations, complaint trending, FDA/ISO regulations.

Keywords: Integrated Resources, Inc, Sandy , Complaint Management, Other , Sandy, Utah

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