Director of Quality Assurance

Job Details
Description
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

Work arrangement
Yes