Job Summary: The Complaint Handling 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)
- 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.
- Data analysis 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.
- Works under general supervision. Uses discretion to determine own work priorities.
- 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.
- 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.
Skills and Experiences:
- 2+ years experience in a quality or customer service/complaint resolution.
- Experience with MS Office applications including: Word, Excel, Access, and Outlook
- Proven ability to communicate effectively, orally, and in writing.
- Proven ability to maintain confidentiality and discretion in business relationships and exercise sound business judgement.
- Ability to use/create databases and prepare documents.
- Minimum two (2) years complaint investigation or customer service resolution experience
- Bachelor’s degree.
- Bachelor of Science degree in a Technical, Engineering, Medical or Related field
- Demonstrated presentation, communication and writing skills.
- Experience with date processing and analyses.
- 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.
- Ability to maintain confidentiality and discretion in business relationships and exercise sound business judgment.
- ASQ qualification
- Bachelor’s degree.