Director of Quality Assurance

Job Details Description Competencies & Skills Quality Systems Leadership – Leads, maintains, and continuously improves a compliant and scalable Quality Management SystemRegulatory Compliance – Applies FDA, ISO 13485, design control, CAPA, risk management, validation, and post-market requirements to quality operationsAudit & Inspection Leadership – Directs readiness and response for FDA inspections, notified body audits, customer audits, and other external assessmentsCAPA & Root Cause Analysis – Drives rigorous investigations, corrective and preventive actions, effectiveness verification, and trend analysisRisk-Based Decision Making – Uses quality data, product risk, and regulatory requirements to prioritize issues and guide business decisionsTeam Leadership & Development – Builds, develops, and holds quality teams accountable for strong execution and technical excellenceContinuous Improvement – Translates quality metrics and operational data into sustainable process and system improvementsExecutive Communication & Collaboration – Communicates quality risks, trends, priorities, and recommendations clearly across leadership and cross-functional teams Key Responsibilities Quality Management System & Compliance Lead the implementation, maintenance, and continuous improvement of the company’s Quality Management System (QMS)Ensure compliance with applicable FDA Quality System requirements, ISO 13485, and other regulatory standardsDevelop and maintain quality policies, procedures, work instructions, quality plans, and documentation controlsEvaluate QMS effectiveness through metrics, audits, management review, and continuous improvement activities while driving a strong culture of quality Regulatory & Inspection Readiness Serve as the primary quality representative during FDA inspections, notified body audits, customer audits, and other external assessmentsLead audit preparation, response activities, corrective actions, follow-up commitments, and ongoing inspection readinessEnsure quality documentation and records remain complete, compliant, and audit-ready Quality Operations & Continuous Improvement Lead investigations involving nonconforming product, complaints, deviations, and quality system issuesOversee root cause analysis, CAPA, effectiveness verification, trend analysis, and escalation of significant quality risksEstablish and monitor key quality performance indicators and use quality and operational data to drive continuous improvementDirect risk management activities throughout the product lifecycle Product, Process & Supplier Quality Oversee design controls, verification and validation, process validation, change control, and quality requirements throughout product development and commercializationProvide quality oversight for manufacturing operations, supplier controls, and incoming, in-process, and final inspectionsReview and approve quality documentation supporting product release and manufacturing operationsEstablish and maintain supplier qualification, monitoring, auditing, performance measurement, quality agreements, and supplier corrective action programs Leadership & Executive Reporting Recruit, develop, mentor, and lead quality personnel while fostering a collaborative, accountable, and high-performance organizationSupport employee training and competency programs related to quality systems and regulatory requirementsPrepare and present quality metrics, trends, risks, and improvement initiatives to executive leadership and lead management review activitiesProvide strategic recommendations regarding quality resources, infrastructure, organizational development, and board-level quality reporting as required Qualifications Bachelor’s degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related technical field; master’s degree preferred8–10 years of progressive quality experience in the medical device industry, including 3–5 years of leadership experience managing quality teamsStrong working knowledge of FDA Quality System requirements, ISO 13485, design controls, CAPA, ISO 14971 risk management, process validation, supplier quality management, complaint handling, and post-market surveillanceDemonstrated experience leading FDA inspections and ISO certification audits and successfully implementing or improving Quality Management SystemsExperience with Class I and/or Class II medical devices and product development or commercialization preferredASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent certification preferredExcellent communication, leadership, project management, cross-functional collaboration, and data-driven problem-solving skills