Director of Quality Assurance

Job Title: Director of Quality Assurance – Tissue Processing

Department: Quality Assurance / Regulatory Affairs

Reports To: Executive Leadership

FLSA Status: Exempt

The Director of Quality Assurance is responsible for providing strategic leadership, direction, and oversight to the company’s Quality Management System (QMS) to ensure compliance with international and domestic tissue processing regulations, standards, and corporate policies. This role establishes quality strategy, directs organizational compliance programs, and ensures alignment with corporate objectives across all quality assurance processes, including regulatory compliance, internal and external audits, risk management, supplier quality, and continuous improvement initiatives.

The Director of Quality Assurance serves as a key member of the leadership team, providing executive-level guidance on quality strategy and regulatory risk management, ensuring the delivery of safe and effective products that meet or exceed customer and regulatory requirements.

• Lead the implementation, maintenance, and improvement of the QMS in compliance with cGMPs, ISO 13485:2016, ISO 14971:2019, and FDA 21 CFR Part 11, Part 820, Part 361/1271, and the relevant FDA Guidance documents for these regulations.
• Provide oversight of product release strategy and ensure compliance through delegated authority.
• Establish and oversee policies for raw material acceptance, supplier controls, and product disposition.
• Ensure organizational compliance with labeling and packaging requirements through policy, audit, and review.
• Plan, manage, and resource internal audits, supplier audits, and regulatory inspections; serve as the host and primary point of contact for regulatory and notified body representatives.
• Assure programs related to document control, GMP training program, and controlled record management are in compliance.
• Direct Quality approval for the CAPA process, including nonconformance handling, root cause analysis, corrective/preventive action planning, and effectiveness verification.
• Provide oversight and guidance for product risk management in accordance with ISO 14971. Perform the quality review function for device pFMEA/dFMEA and design control through delegation to appropriately trained and qualified staff.
• Review and approve quality-related documentation, including validation protocols, verification reports, design control deliverables, and batch records.
• Develop the key quality metrics for the periodic QMSR (Quality Management Systems Review) to drive systemic improvements, enhancing compliance and operational effectiveness.
• Develop, mentor, and direct the Quality team and oversee staff development across multiple quality functions to ensure alignment with company goals and regulatory expectations.
• Partner with cross-functional teams (Process Engineering, Manufacturing, Warehouse/Distribution, Regulatory Affairs, Operations, Sales) to support quality throughout the product lifecycle.
• Competency and proficiency in making standard Regulatory submissions, updates, and communications, such as FDA Establishment Registrations, 510(k) s, State Registrations, and FSCA for Medical Devices.
• Ability to guide the organization to compliantly launch new medical device products and configurations to market.

• Bachelor’s degree in Engineering, Life Sciences, Quality, or related field; advanced degree strongly preferred.
• Minimum of 10–12 years of progressive experience in tissue processing quality assurance, with at least 5+ years in a director-level or equivalent leadership capacity.
• Comprehensive knowledge of ISO 13485, FDA 21 CFR Part 820, ISO 14971, and EU MDR.
• Demonstrated experience and favorable outcomes with FDA inspections, notified body audits, and supplier quality programs.
• Expertise in QMS software platforms and document control systems.
• Strong analytical, problem-solving, and decision-making skills.
• Professional certifications CQA, CQE, LSSBB, or RAC.
• Executive leadership and organizational management skills.
• Regulatory compliance expertise.
• Effective communication and presentation abilities, including…