Quality Systems Engineer, Senior (Medical Devices)

TL;DR

Quality Systems Engineer, Senior (Medical Devices): Developing and maintaining quality management systems for orthopedic medical devices with an accent on regulatory compliance, CAPA, nonconformance management, and audit readiness. Focus on validating electronic QMS solutions, leading cross-functional investigations, and presenting quality and training metrics during governance and management reviews.

Location: Onsite in Gainesville, Florida, United States

Company

hirify.global develops orthopedic implants, instruments, and technologies designed to improve surgical outcomes and mobility.

What you will do

• Lead the administration, maintenance, and strategic development of the Quality Management System in alignment with FDA, ISO 13485, MDSAP, EU MDR, and other applicable standards.
• Oversee CAPA and nonconformance systems, including system validation, investigations, root cause analysis, effectiveness verification, escalation, and disposition decisions.
• Manage product event escalations, health hazard evaluations, product corrections, and removals based on product risk.
• Serve as a lead subject matter expert during internal and external audits and regulatory inspections.
• Oversee the Learning Management System and develop quality training, competency solutions, and related performance metrics.
• Compile process data, report quality and training KPIs, and facilitate Quality Systems Governance and Management Review meetings.

Requirements

• Bachelor’s degree in engineering or a related science field from an accredited institution; a master’s degree is preferred.
• At least 6 years of full-time medical device engineering, quality, or regulatory technical experience.
• Knowledge of domestic and international Quality System regulations and experience operating within a Quality Management System.
• Experience developing, implementing, maintaining, and validating electronic QMS solutions for CAPA, audits, data analysis, and related processes.
• Professional certification through the American Society for Quality or an equivalent medical device auditing certification.
• Ability to lead cross-functional teams and projects and communicate effectively in quality-related discussions.

Nice to have

• Experience with change management documentation systems.
• Experience with electronic QMS platforms such as SmartSolve IQVIA, Cornerstone, or Teamcenter.
• Experience with data management and reporting in Power BI.

Culture & Benefits

• Innovation-focused medical device environment.
• Work directly on quality systems supporting orthopedic implants, instruments, and surgical technologies.
• Cross-functional collaboration across quality, regulatory, engineering, and operational teams.

Hiring process

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