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.

Job Description:

• 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 facilitate 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

• 4-year technical degree in engineering or a scientific discipline
• 8 years in an FDA-regulated medical device environment
• Certified Quality Manager or Certified Quality Auditor Certification(s)
• Experience in developing and improving quality management systems
• Knowledge of documentation systems, specifically new product development (protocols, reports, software, validation data, Design History Files), quality systems (procedures, forms, quality records), and manufacturing (Bill of Material, travelers, procedures, Device History Records, Device Master Records).
• Direct experience maintaining procedures as they relate to the FDA Quality System regulations and ISO 13485
• Exposure to 21 CFR Part 11 and Computer/Quality System Software management methods
• Experience with ISO 14971 and applying a risk-based approach to product development and manufacturing

• Familiarity with FDA, ISO 13485, ISO 14971 Quality Systems and Risk Management requirements
• Ability to identify and…