Director of Quality Assurance

The Dirctor of Quality Assurance leads the organization's quality strategy, ensuring that products and processes meet regulatory and industry standards. This role drives continuous improvement initiatives, maintains quality certifications, and promotes a strong culture of quality throughout the organization.

Key Responsibilities

Leadership & Department Management

• Lead and manage the Quality Assurance department, including hiring, training, development, and performance management.
• Ensure team accountability for achieving quality goals and departmental deliverables.

Supplier Quality

• Oversee supplier approval, audits, performance monitoring, and corrective actions.

Product Quality Support

• Provide quality engineering support for sustaining engineering activities.
• Support new product development and design transfer from a quality and regulatory standpoint.

Quality Systems & Documentation

• Manage the document change control process and approve changes to drawings, specifications, and procedures.
• Evaluate design/process impacts from a regulatory perspective.
• Oversee QA engineering activities for both development and sustaining efforts.

Risk Management

• Lead risk management efforts in compliance with ISO 14971.
• Oversee creation and maintenance of FMEAs, risk assessments, and risk management files.

Nonconformance & CAPA

• Lead the Material Review Board (MRB) and manage nonconforming material processes.
• Maintain and monitor corrective and preventive action (CAPA) programs.

Audits & Compliance

• Conduct internal audits to ensure compliance with quality system and regulatory requirements.
• Ensure adherence to applicable regulations, including FDA, ISO 13485, MDD/MDR, and other global medical device standards.

Regulatory & Certification Activities

• Serve as liaison during external regulatory and certification audits.
• Support regulatory submissions and creation/maintenance of technical documentation.

Quality Metrics & Reporting

• Collect, analyze, and report key quality indicators for management review.

Other Responsibilities

• Comply with organizational policies, procedures, and ethical standards.
• Perform additional duties as needed to support business operations.

Qualifications

Required

• Bachelor's degree in Engineering, Biological Sciences, or related technical field.
• Minimum 10 years of experience in medical device quality or manufacturing; medical electronics experience preferred.
• Strong ability to interpret engineering drawings and specifications.
• Highly organized with excellent verbal and written communication skills.
• Proficiency with Microsoft Word, Excel, PowerPoint, and experience with electronic document control and ERP systems.
• Experience with FDA eMDR reporting.
• Certified ISO 13485 Lead Auditor (or equivalent).
• In-depth understanding of FDA, MDD/MDR, and related regulations.
• At least 5 years of management experience leading teams and driving performance.

Preferred

• ASQ certifications (e.g., CMQ/OE, CQE, CQA, CSQP).
• MDR training or equivalent certification.
• Class III device experience