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Post Market Quality Assurance Specialist

2 months ago

Gainesville, Florida, United States Exactech Full time
Job Overview

The QA Post Market Specialist plays a crucial role in managing complaint handling processes to uphold regulatory standards and enhance customer satisfaction. This position is responsible for coordinating and submitting necessary regulatory documentation to the FDA and relevant regional authorities.

Key Responsibilities
  • Manage the receipt, documentation, investigation, and resolution of customer complaints to ensure adherence to regulatory standards (e.g., FDA, CMDR, ISO) and maintain customer satisfaction.
  • Follow all Exactech protocols and guidelines while evaluating complaint incidents for regulatory reporting obligations.
  • Prepare and submit regulatory reports to the FDA or regional authorities within specified timelines.
  • Identify and escalate high-severity incidents to management for further action.
  • Assist in achieving departmental metrics and key performance indicators related to complaint management.
  • Support audit processes and respond to audit inquiries regarding complaints.
  • Contribute to continuous improvement initiatives and special projects as assigned.
  • Provide training and support to team members involved in complaint handling.
  • Help in the development or revision of procedures, work instructions, forms, reports, and templates to standardize departmental practices.
  • Apply knowledge of Exactech's Quality System along with relevant FDA and international standards to assist and support colleagues and sales teams as needed.
QualificationsEducation:
  • Associate's Degree from an accredited institution is required; a Bachelor's Degree is preferred.
Experience:
  • Preferred degree in Allied Health, Statistics, Epidemiology, Life Sciences, or Biomedical Engineering.
  • A minimum of 1 year of experience in complaint handling or post-market surveillance within a Medical Device or Pharmaceutical FDA-regulated environment.
  • If lacking direct complaint handling experience, at least 2 years in a quality assurance role within a Medical Device or Pharmaceutical FDA-regulated setting is acceptable.
  • Familiarity with FDA, EU, and other global regulations pertaining to complaint handling and recalls/FSCA is essential.
  • Experience with FDA/ISO quality management system regulations is required.
  • Proficiency in quality system management software is highly desirable.
Skills and Abilities:
  • Proficient in Windows-based office productivity applications.
  • Exceptional analytical abilities with a keen attention to detail.
  • Strong organizational and time management capabilities.
  • Excellent written, verbal, and presentation communication skills.
  • Ability to consistently maintain high standards of accuracy in documentation and data analysis.
  • Self-motivated with the ability to prioritize tasks and work independently to meet deadlines.