Director of Quality Assurance

Quality Systems Leadership Position

Competencies & Skills

• Quality Systems Leadership – Leads, maintains, and continuously improves a compliant and scalable Quality Management System
• Regulatory Compliance – Applies FDA, ISO 13485, design control, CAPA, risk management, validation, and post-market requirements to quality operations
• Audit & Inspection Leadership – Directs readiness and response for FDA inspections, notified body audits, customer audits, and other external assessments
• CAPA & Root Cause Analysis – Drives rigorous investigations, corrective and preventive actions, effectiveness verification, and trend analysis
• Risk-Based Decision Making – Uses quality data, product risk, and regulatory requirements to prioritize issues and guide business decisions
• Team Leadership & Development – Builds, develops, and holds quality teams accountable for strong execution and technical excellence
• Continuous Improvement – Translates quality metrics and operational data into sustainable process and system improvements
• Executive 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 standards
• Develop and maintain quality policies, procedures, work instructions, quality plans, and documentation controls
• Evaluate 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 assessments
• Lead audit preparation, response activities, corrective actions, follow-up commitments, and ongoing inspection readiness
• Ensure quality documentation and records remain complete, compliant, and audit-ready
• Quality Operations & Continuous Improvement
• Lead investigations involving nonconforming product, complaints, deviations, and quality system issues
• Oversee root cause analysis, CAPA, effectiveness verification, trend analysis, and escalation of significant quality risks
• Establish and monitor key quality performance indicators and use quality and operational data to drive continuous improvement
• Direct 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 commercialization
• Provide quality oversight for manufacturing operations, supplier controls, and incoming, in-process, and final inspections
• Review and approve quality documentation supporting product release and manufacturing operations
• Establish 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 organization
• Support employee training and competency programs related to quality systems and regulatory requirements
• Prepare and present quality metrics, trends, risks, and improvement initiatives to executive leadership and lead management review activities
• Provide 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 preferred
• 8–10 years of progressive quality experience in the medical device industry, including 3–5 years of leadership experience managing quality teams
• Strong 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 surveillance
• Demonstrated experience leading FDA inspections and ISO certification audits and successfully implementing or improving Quality Management Systems
• Experience with Class I and/or Class II medical devices and product development or commercialization preferred
• ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent certification preferred
• Excellent communication, leadership, project management, cross-functional collaboration, and data-driven problem-solving skills

Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.