Job 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