Director of Quality Engineering

Director of Quality EngineeringBackground: 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.