What are the responsibilities and job description for the Director of Quality Assurance position at Confidencial?
The Director of Quality Assurance is a key leadership role responsible for the strategic oversight and execution of the company’s Quality Assurance programs. This individual will ensure that all tissue banking operations and medical device products comply with applicable regulations, standards, and company policies, including FDA (21 CFR Part 1271 & 820), AATB, and ISO 13485. The Director will lead QA initiatives, manage compliance and audit readiness, and collaborate closely with cross-functional leaders to drive a culture of quality across the organization.
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Key Responsibilities
• Develop, lead, and continuously improve the company’s Quality Assurance programs in alignment with regulatory, accreditation, and internal standards.
• Oversee quality system elements including document control, CAPA, complaints, change control, risk management, and training.
• Ensure compliance with FDA regulations (21 CFR Part 1271, 820), AATB standards, ISO 13485, and other applicable requirements.
• Serve as the primary contact for regulatory inspections, customer audits, and AATB accreditation site visits.
• Provide strategic guidance on quality-related matters to senior leadership and across departments.
• Lead and mentor a team of QA professionals, promoting professional development and accountability.
• Collaborate with Manufacturing, QC, Regulatory, and R&D to support product development, validation, and commercialization.
• Manage internal audit programs and ensure the timely closure of audit findings and CAPAs.
• Lead quality review board (QRB) meetings and quality metric reporting to executive leadership.
• Ensure timely and compliant batch record review, product release, and deviation handling.
• Support continuous improvement initiatives through trend analysis, root cause investigations, and risk-based decision-making.
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Qualifications
• Bachelor’s degree in Life Sciences, Engineering, or a related field (Master’s or advanced degree preferred).
• Minimum of 10 years of progressive experience in Quality Assurance within the medical device, biologics, or tissue banking industry.
• At least 5 years in a senior leadership role managing quality systems and teams.
• Deep understanding of applicable regulations including 21 CFR Part 1271, 21 CFR Part 820, AATB, and ISO 13485.
• Demonstrated success in hosting regulatory and third-party audits.
• Experience with quality systems implementation and digital QMS tools.
• Strong leadership, communication, and decision-making skills.
• Ability to build cross-functional relationships and influence at all organizational levels.
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Preferred Certifications
• Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), or equivalent.
• AATB certification or significant tissue banking experience strongly preferred.
