Director of Quality

Overview

Tympanogen is a medical device company based in Richmond, VA with a mission to improve healthcare by simplifying surgical procedures. We develop gel‑based medical devices for the ear, nose, and throat industry and are preparing to launch our first product.

We are seeking an experienced Director of Quality who will be responsible for developing, executing, and maintaining a quality system and quality control processes in full compliance with FDA, ISO and other global regulatory requirements. Functional activities include document control, change control, design review, record review, training management, manufacturing support, risk management and non‑conformance / CAPA / complaint resolution. The Director of Quality is responsible for ensuring all departments follow the company’s quality procedures and will be required to utilize process improvement methodologies and risk‑based principles to identify opportunities, develop and execute improvement plans, and monitor activities to ensure a proactive state of compliance.

This position reports to the CEO and will start with one direct report. A visionary candidate who can be both hands‑on with developing and executing quality deliverables and effectively lead a growing department would thrive in this role.

• Support, maintain and continuously improve the existing company electronic Quality Management System (eQMS) in accordance with regulatory requirements; especially requirements specified in 21 CFR Part 820, ISO 13485, ISO 14971 and other global medical device regulations
• Develop and implement post‑market quality plan and documents alongside manufacturing efforts in accordance with regulatory requirements
• Interpret and provide guidance on applicable and upcoming federal and international regulations and implement updates to company eQMS as necessary
• Apply process analysis/development tools to create and continuously improve procedures required to maintain compliance and business efficiency (e.g., fishbone diagrams, flowcharts, statistical applications)
• Support manufacturing and product development teams in design transfer and iterative product development
• Generate and improve metrics required to establish the overall suitability and effectiveness of the QMS
• Participate in Design Reviews and Risk Management reviews
• Assist in maintaining and updating internal and external standards. Work with Subject Matter Experts to ensure gap analysis is performed to ensure continued compliance
• Provide technical support for company personnel regarding the eQMS
• Lead internal and external audits and audit‑preparation activities
• Develop, administer, and continuously improve the training required to support the effectiveness and suitability of the eQMS. This requirement includes the development, implementation and maintenance of specific Instructor‑Led Training courses such as cGMP Compliance, Good Documentation Practices, Risk Management and Process Development
• Responsible for handling complaints, non‑conformances, and the CAPA process
• Responsible for creating a Management Review Process and serves as the Management Representative

• Responsible for creating and supporting the Document Control functions within the eQMS
• Ensure the consistency and quality of documents within the change control process
• Perform process training for document creation and document control processes

• Assists team in investigating and documenting non‑conformance issues, determining root causes and implementing corrective actions
• Resolves document issues and facilitates sampling or rejection of materials in a timely manner
• Responsible for implementing a Quality Control program to monitor manufacturing processes and support product release
• Create a Product Release process for consistent batch release including label reconciliation, batch review and generation of appropriate Quality certificates.

• Establish and maintain a robust supplier and supply management program including supplier/supply qualification, SCAR process and ongoing monitoring
• Establish and oversee the supplier audit program