Complaint Handling Analyst II

Complaint Handling Analyst II

15 Oct 2024
Texas, Ustx 00000 Ustx USA

Complaint Handling Analyst II

Vacancy expired!

Job Description

The Complaint Analyst II is responsible for:

1) the analyses and control of medium to highly complex diverse (KCI, Systagenix technical and medical) complaint investigations received from global external customers within procedural and regulatory requirements (e.g. Food and Drug Administration (FDA), International Standards Organization (ISO), Quality System Requirements (QSR)) guidelines, and

2) facilitating diverse complaint investigation activities with cross-functional team members to prepare complaint investigation reports.

Principle Responsibilities (essential job duties and responsibilities):

  • Works independently to investigate medium to highly complex complaints (e.g. MDR reportable, international reportable, Systagenix, etc.) in compliance with company procedures using designated databases.
  • Works under minimum supervision. Uses discretion to determine their own work priorities.
  • Author reports and customer responses based on findings obtained from complaint investigations.
  • Responsible for prescreening assigned complaints, both domestic and international, to ensure the record contains the information required by the FDA and/or other regulatory bodies and make diligent attempts to obtain the required information is missing.
  • Responsible for forwarding all potentially reportable complaints to the Medical Compliance team in a timely manner.
  • Ensures appropriate failure mode classifications are assigned to allow precise trending for data analysis purposes.
  • Routine and non-routine cross-functional contacts often requiring the ability to interpret, adapt, and explain information received from multiple sources including internal and external customers.
  • Analyzing complaint data that is routine to complex and generally guided by established policy or procedures.
  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
  • Demonstrates good judgment in selecting methods and techniques to acquire information to arrive at conclusions.
  • Receives and acts upon detailed instructions from management related to new projects or assignments.
  • Guides/trains others in areas of specialty while continuing to carry out responsibilities in own area.
  • Plays a mentoring/coaching role with co-workers in a cross-functional team situation.
  • Performs validation activities for databases used in Complaint Handling and other cross-functional systems.
  • Decisions impact data associated with complaint records and could have a significant regulatory impact including FDA 483 (significant finding during FDA inspection), FDA Warning Letter, and inability to export products.

Qualifications

Minimum Qualifications:

  • High School Diploma or equivalent (e.g., GED) with a minimum of 5 years of experience as a complaint investigation or customer service resolution specialist OR
  • Bachelor of Science degree in a Technical, Engineering, Medical, Life Sciences or related field with a minimum of 2 years of experience as a complaint investigation or customer service resolution specialist

Other Qualifications:

  • Proven ability to communicate effectively, orally, and in writing
  • Proven ability to maintain confidentiality and discretion in business relationships and exercise sound business judgment
  • Ability to use databases and prepare documents
  • Experience with Microsoft Office applications including Word, Excel, and Outlook.
  • Participation/leader in quality process improvement initiatives

Preferred Qualifications:

  • Experience with data processing and analyses
  • Experience with regulatory requirements and/or medical devices
  • Advanced wound therapeutics product knowledge
  • Ability to work individually and as part of a team
  • Ability to work effectively with all employees and external business contacts while conveying a positive attitude
  • ASQ qualification

Additional Information

Message me or email your resume to sandhya.v at tekwissen dot com Whether you are looking for that next move in your career, or just want more info I am happy to chat!

Job Details

  • ID
    JC5036674
  • State
  • City
  • Job type
    Contract
  • Salary
    N/A
  • Hiring Company
    TEKWISSEN LLC
  • Date
    2020-10-15
  • Deadline
    2020-12-14
  • Category

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