Director, Quality Engineering (Medical Devices)

Location: Gainesville, Florida, United States; onsite

Company

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

What you will do

• Establish and oversee Quality Engineering strategy across FDA, ISO 13485, MDSAP, EU MDR, and internal QMS requirements.
• Lead, develop, and scale the Quality Engineering organization, including objectives, resources, leadership capability, and team priorities.
• Provide executive oversight of design controls, risk management, verification and validation, process validation, GD&T, inspection strategy, and statistical quality requirements.
• Direct root cause analysis, CAPA strategy, complaint and nonconformance processes, containment, disposition, and risk escalation.
• Define and communicate quality metrics, trends, and risk indicators for management review and quality governance.
• Represent Quality Engineering during internal and external audits, notified body assessments, FDA inspections, and regulatory inspections while partnering with Operations, R&D, Regulatory Affairs, Clinical, Supply Chain, and executive stakeholders.

Requirements

• Bachelor’s degree in Science from an accredited institution; a master’s degree is preferred.
• At least 12 years of progressive quality, engineering, manufacturing, or regulatory experience, preferably in orthopedics or medical devices.
• At least 8 years of leadership experience in Quality Engineering, Quality Assurance, or a related medical device function.
• Advanced knowledge of inspection strategy, specification development, statistical techniques, gage R&R, GD&T, process validation, and risk-based quality decisions.
• Significant experience representing Quality Engineering during FDA inspections, notified body audits, customer audits, and senior-level quality governance forums.
• Executive-level communication, leadership, business acumen, and cross-functional influence.

Culture & Benefits

• Work is performed onsite in Gainesville, Florida.
• Focus on innovation in orthopedic implants, instruments, surgical experience, and patient outcomes.

Hiring process

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