Senior Quality Engineer (Medical Devices)

TL;DR

Senior Quality Engineer (Medical Devices): Providing end-to-end quality engineering support for an orthopedic joint product portfolio with an accent on regulatory compliance, risk management, and design controls. Focus on leading verification and validation strategies, managing CAPA processes, and ensuring product quality throughout the full lifecycle from development to post-market support.

Location: Onsite in Gainesville, FL

Company

hirify.global is an innovative medical technology company focused on developing advanced orthopedic implants and instruments to improve patient mobility and surgical outcomes.

What you will do

• Serve as the Quality Engineering lead for a designated product line throughout the full product lifecycle.
• Lead quality activities for new product development, ensuring compliance with FDA and ISO standards.
• Drive risk management activities including DFMEA, hazard analysis, and lifecycle risk file maintenance.
• Manage verification and validation strategies, documentation, and process validation (IQ/OQ/PQ).
• Collaborate with cross-functional teams to resolve nonconformances, CAPAs, and customer complaints.
• Analyze field performance data to identify trends and drive continuous improvement initiatives.

Requirements

• Bachelor’s Degree in Engineering.
• 5+ years of experience in the medical device or a highly regulated industry.
• Deep understanding of design controls, ISO 14971 risk management, and statistical analysis.
• Working knowledge of FDA 21 CFR Part 820 and ISO 13485.
• Experience with CAPA, root cause analysis, and change control systems.
• Must be able to work onsite in Gainesville, FL.

Nice to have

• Advanced degree in Engineering.
• Specific experience with orthopedic implants or joint systems.
• Familiarity with GD&T and inspection systems.

Culture & Benefits

• Focus on innovation in surgical experiences and orthopedic technology.
• Opportunity to work on revolutionary medical products that improve patient freedom.
• Collaborative environment partnering with R&D, Manufacturing, and Regulatory teams.

Hiring process

• Initial Interview.
• Hiring Manager and Team Interview(s).
• Final Selection.
• Offer.