Director of Quality Engineering

Background

Our client is seeking a Director of Quality Engineering to lead Sustaining Quality and Design Quality for commercialized capital equipment and software/hardware-based medical devices. This leader will oversee post-market quality strategy, design control execution, and manufacturing quality support, ensuring products remain compliant, reliable, and audit-ready throughout the lifecycle.

The role requires strong experience operating within FDA 21 CFR Part 820 and ISO 13485 environments, with deep expertise in design controls, verification & validation, regulatory submissions, and sustaining engineering.

Project

• Lead quality engineering for sustaining programs across released medical devices.
• Oversee design changes, risk assessments, and change control in compliance with 21 CFR 820, ISO 13485, and ISO 14971.
• Ensure integrity of DHFs, DMRs, DHRs, and risk management files.
• Drive investigations, complaint handling, NCRs, and CAPA to protect product quality and revenue.
• Partner with R&D to translate user needs and design inputs into compliant engineering deliverables.
• Oversee verification, validation, test method validation, equipment qualification, and process validation activities.
• Support 510(k), IDE, and other regulatory submissions related to sustaining changes.
• Lead supplier quality oversight, including qualification and ongoing performance management.
• Represent Quality in cross-functional forums and regulatory inspections.
• Build and develop a high-performing Quality Engineering team.

Required Skills

• Bachelor’s degree in Engineering or related technical discipline.
• 8+ years of experience in medical device quality and product development.
• Strong background in sustaining engineering and design control management.
• Experience supporting manufacturing operations and supplier quality.
• Demonstrated success operating within FDA-regulated and ISO-compliant QMS environments.
• Proven leadership and cross-functional communication skills.