QA PM Specialist
On-siteGainesville, Florida, United States
Job Summary
Manage receipt, documentation, investigation, and closure of customer complaints to ensure regulatory compliance with FDA, CMDR, and ISO standards while supporting audits and continuous improvement projects. Submit regulatory reports to FDA or Regional Competent Authorities within required timeframes and escalate high-severity events to management. Apply Advita's Quality System and global regulations for complaint handling, assisting in training team members and updating procedures, work instructions, and templates. Maintain accuracy in data compilation and analysis while meeting department metrics and key performance indicators.
Required Qualifications
- Associate's Degree from an accredited institution
- Minimum of 1 year of experience performing a complaint handling or post market surveillance role in a Medical Device or Pharmaceutical FDA regulated environment
- In lieu of previous complaint handling experience, 2 years of experience in a quality assurance role in the Medical Device or Pharmaceutical FDA regulated environment
- Working knowledge of requirements of FDA, EU, and other global regulations related to complaint handling and Recalls/FSCA
- Experience with FDA/ISO quality management system regulations
- Working knowledge/skill in Windows-based office productivity tools
- Excellent analytical skills
- Detail-oriented
- Strong organizational and time management skills
- Strong written, oral, and presentation communication skills
- Self-directed; capable of setting own priorities and working independently to meet established deadlines
Desired Qualifications
- Bachelor's Degree
- Degree in Allied Health, Statistics, Epidemiology, Life Sciences or Biomedical Engineering
- Experience with quality system management software
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