QA PM Specialist (Medical Devices)

TL;DR

QA PM Specialist (Medical Devices): Handling and investigating customer complaints and coordinating regulatory reporting for an orthopedic medical device company with an accent on FDA, ISO, and international quality requirements. Focus on assessing reportability, escalating high-severity events, supporting audits, and improving post-market quality processes.

Location: Onsite in Gainesville, Florida, United States

Company

hirify.global develops orthopedic implants, instruments, and technologies focused on improving surgical experiences and patient mobility outcomes.

What you will do

• Receive, document, investigate, and resolve customer complaints in accordance with regulatory and quality requirements.
• Assess complaint events for regulatory reporting and submit reports to the FDA or regional competent authorities within required timeframes.
• Escalate high-severity events and cases to management.
• Support complaint metrics, audits, audit requests, and continuous improvement projects.
• Help train complaint team members and maintain procedures, work instructions, forms, reports, and letter templates.
• Apply the company quality system and applicable FDA and international standards while supporting other teams as needed.

Requirements

• Associate's degree from an accredited institution; a bachelor's degree is preferred.
• At least one year of complaint handling or post-market surveillance experience in an FDA-regulated medical device or pharmaceutical environment, or two years of quality assurance experience in such an environment.
• Working knowledge of FDA, EU, and other global regulations covering complaint handling, recalls, and FSCA.
• Experience with FDA and ISO quality management system regulations.
• Analytical, detail-oriented, organized, and able to work independently while meeting deadlines.
• Strong written, oral, and presentation communication skills, with accurate documentation and data analysis abilities.

Nice to have

• Degree in allied health, statistics, epidemiology, life sciences, or biomedical engineering.
• Experience with quality system management software.

Culture & Benefits

• Work onsite within the Quality department.
• Contribute to innovations in orthopedic implants, surgical instruments, and mobility technologies.
• Participate in continuous improvement initiatives and cross-functional collaboration.

Hiring process

• Initial interview.
• Hiring manager and team interviews.
• Final selection followed by an offer.