Director, Quality Engineering

About the role

The Director, Quality Engineering provides strategic leadership and functional oversight for the Quality Engineering organization, aligning quality strategy, regulatory compliance, product realization, and continuous improvement with business objectives.

Key responsibilities

• Establish and oversee Quality Engineering strategy to ensure compliance with FDA, ISO 13485, MDSAP, EU MDR, and internal QMS requirements.
• Lead, develop, and scale the Quality Engineering function, setting objectives and allocating resources.
• Provide executive oversight of design controls, risk management, verification/validation, process validation, GD&T, inspection strategy, and statistical quality across design transfer and manufacturing.
• Direct systemic root‑cause analysis, corrective and preventive action (CAPA) strategy, and cross‑functional remediation.
• Oversee complaint, non‑conformance, containment, disposition, and escalation processes.
• Define, monitor, and communicate quality performance metrics, trends, and risk indicators.
• Serve as senior leader during internal and external audits, notified‑body assessments, and regulatory inspections.
• Partner with Operations, R&D, Regulatory Affairs, Clinical, Supply Chain, and executive stakeholders to resolve complex issues and improve quality outcomes.

Required profile

• Bachelor’s degree in Science (Master’s preferred).
• Minimum 12 years of progressive quality, engineering, manufacturing, or regulatory experience, preferably in orthopedic or medical device environments.
• At least 8 years of leadership experience in Quality Engineering.
• Proven ability to establish, lead, and improve Quality System processes and governance mechanisms.

Required skills

• FDA regulations
• ISO 13485
• MDSAP
• EU MDR
• Design controls
• Risk management
• Verification and validation
• Process validation
• GD&T
• Statistical quality methods
• CAPA
• Root‑cause analysis
• Audit and inspection management