QA PM Specialist

QA PM Specialist

Department: Quality

Employment Type: Full Time

Location: Gainesville, FL

Reporting To: Manager, Post Market

Description

The purpose of the QA Post Market Specialist is to perform complaint handling activities to ensure regulatory compliance and customer satisfaction. This role coordinates and submits regulatory reports to FDA and Country/Regional competent authorities.

Key Responsibilities

• Engaged in the receipt, documentation, investigation, and closure/resolution of customer complaints to ensure regulatory compliance (e.g., FDA, CMDR, ISO) and customer satisfaction.
• Adhering to all Advita procedures and requirements. Assesses complaint events for regulatory reporting requirements.
• Submits regulatory reports to FDA or Regional Competent Authority within regulatory timeframes.
• Escalates high severity events and cases to Management.
• Supports the completion of complaint activities in line with department metrics and key performance indicators.
• Supports audits and audit requests for complaints.
• Assists with continuous improvement activities and/or special projects, as assigned.
• Assists in training complaint team members.
• Assists in updates or creation of procedures, work instructions, forms, reports and letter templates to standardize departmental processes.
• Knowing and applying Advita's Quality System and any appropriate FDA and international standards.
• Assist and support other employees, teams, and sales personnel, as necessary.

Skills Knowledge and Expertise

Education:

• Associate''s Degree from an accredited institution required; Bachelor''s Degree preferred.

Experience:

• Degree in Allied Health, Statistics, Epidemiology, Life Sciences or Biomedical Engineering, highly preferred.
• 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 required.
• Experience with FDA/ISO quality management system regulations required.
• Experience with quality system management software highly preferred.

Functional/Technical Knowledge, Skills and Abilities Required:

• Working knowledge/skill in Windows-based office productivity tools.
• Excellent analytical skills and detail-oriented.
• Strong organizational and time management skills.
• Strong written, oral, and presentation communication skills. Ability to consistently meet high standards of input accuracy, produce quality documents, compile data, and perform simple analyses with accuracy. Self-directed; capable of setting own priorities and working independently to meet established deadlines.