QA Post Market Engineer (Medtech)

TL;DR

QA Post Market Engineer (Medtech): Supporting post-market surveillance by performing product complaint investigations and root cause analysis with an accent on regulatory compliance and product safety. Focus on evaluating orthopedic implants and instruments, conducting risk assessments, and managing quality system processes like CAPAs.

Location: Onsite in Gainesville, FL

Company

hirify.global focuses on innovation in orthopedic implants and instruments to optimize surgical experiences and improve patient mobility.

What you will do

• Conduct complaint investigations, including product analysis, testing, and root cause determination.
• Perform risk assessments and review complaint trends and history.
• Document investigation activities in compliance with internal procedures and FDA/ISO regulatory standards.
• Collaborate with cross-functional teams to resolve product issues and escalate findings.
• Support quality system processes, including CAPAs, HHEs, and NCRs.
• Draft investigation summaries and responses for customers.

Requirements

• Bachelor’s degree in Engineering (Mechanical or Biomedical preferred).
• Foundational knowledge of mechanical design, GD&T, CAD, and materials analysis.
• Experience or exposure to root cause analysis, risk assessment, and technical documentation.
• Must be based in or able to work onsite in Gainesville, FL.
• Familiarity with FDA/ISO quality systems and medical device regulations.

Culture & Benefits

• Innovation-driven environment focused on cutting-edge orthopedic technology.
• Opportunity to impact patient outcomes and mobility through product improvement.
• Collaborative work culture within a specialized Quality department.
• Full-time employment with a focus on continuous improvement and professional training.