The Sr. Complaint Analyst I is a member of the Complaint Handling Group and reports to a Complaint Handling Manager or Sr. Regulatory Manager. The Sr. Complaint Analyst I ensures accurate entry of complaints into the Complaint Handling Database and completion of all levels of complaint investigations either through direct completion or peer review of complaint data from all feeder systems. The Sr. Complaint Analyst I works within the guidelines of Complaint Handling and Global Adverse Event Reporting procedures to ensure compliance with Food and Drug Administration (FDA), International Standards Organization (ISO), Quality System Regulations (QSR), and other applicable regulatory guidelines as they relate to complaint handling processes. The Sr. Complaint Analyst can oversee the day to day complaint handling operations or complete complaint handling process training (both internal and external to the department) as directed by a departmental Complaint Handling Supervisor, Manager or Regulatory Manager.
Principle Responsibilities (essential job duties and responsibilities):
- Receives all product complaint issues from all automated and manual feeder systems. e.g. Customer First, Hero/Genesis, Excellent, email.
- Provides feedback to feeder systems to obtain corrections to incoming complaint information such as Problem code corrections, requests for additional information, non-product complaints, lot number requests, etc.
- Identifies and assesses potential reportable complaint events or adverse events and assigns and completes or verifies completion of complaint investigations and tasks for self, peers and cross-functional organizations to ensure timely completion of complaint investigations.
- Reviews and approves complaint analyst incoming complaint assessments and completes peer reviews/approvals of complaint investigations to ensure all potential reportable and adverse events are identified and investigated to the level commensurate with the event.
- Oversees the day to day complaint handling operations, project completion, and/or training as directed by management and ensures that each complaint handling team member is working in accordance with their job function.
- Designs, implements, and monitors suitable complaint investigation templates.
- Provides product complaint data to other departments as requested and participates in cross-functional teams, (e.g. Medical, Field Services, Quality, Regulatory Affairs, Quality Engineering, Sustaining Engineering, and Innovation, Sales, Marketing, etc) to ensure accurate assessments are made related to complaint data and trends including initiation of device evaluations, device history record reviews and CAPA investigations.
- Gathers data and creates trend charts, trend statements and other necessary reports to identify adverse trends.
- Perform data analysis of adverse trends to determine if event requires elevation to management.
- 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.
- Contribute or write quality processes for complaint handling or complaint summaries for complaints that have previously been investigated.
- Trains Complaint Handling personnel enabling them to execute the Complaint Handling procedures.
- Trains complaint handling and other cross functional teams in areas of specialty while continuing to carry out responsibilities in own area.
- Mentors and monitors complaint handling team members to ensure each team member is working effectively and within departmental guidelines.
- 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 significant regulatory impact including FDA 483 (significant finding during FDA inspection), FDA Warning Letter, and inability to export products.
- High School Diploma or equivalent (e.g., GED) with a minimum of 7 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 5 years of experience as a complaint investigation or customer service resolution specialist
- Proficiency with Microsoft Office business software and use of information databases
- Keyboarding skills - >35 WPM
- Ability to use databases and prepare documents
- Proven ability to work and maintain a positive environment with peers, management, all KCI employees and customers
- Service oriented attitude
- Proven ability to maintain confidentiality and discretion in business relationships and exercise sound business judgement
- Proven ability to communicate effectively, orally, and in writing
- A minimum of 1 year of experience with advanced wound therapeutics product/process knowledge
- Participation/leader in quality process improvement initiatives
- Experience with date processing and analyses
- 3 years of experience with regulatory requirements and/or medical devices
- 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 or RAPS member.