Position Summary:
The QC Manager is responsible for overseeing and managing all aspects of Quality Control operations to ensure compliance with FDA regulations, AATB standards, ISO requirements, and internal procedures. This individual will play a key leadership role in managing the day-to-day QC activities for tissue-based medical devices and materials, ensuring that products meet rigorous quality and safety standards throughout the lifecycle—from raw tissue receipt through final product release.
Key Responsibilities:
• Lead and manage the QC team, including analysts, technicians, and support staff.
• Develop, implement, and maintain QC testing procedures, methods, and protocols specific to human tissue and related medical devices.
• Oversee in-process, final product, and environmental testing, ensuring timely and accurate results.
• Ensure compliance with applicable regulatory requirements (FDA 21 CFR Part 1271, 21 CFR Part 820, AATB standards, ISO 13485, etc.).
• Manage quality control documentation, including testing records, validation protocols, and equipment calibration logs.
• Participate in internal and external audits, inspections, and regulatory submissions.
• Review and approve QC data, batch records, and Certificates of Analysis (CoAs).
• Monitor key quality indicators (KQIs) and develop corrective/preventive actions (CAPAs) as needed.
• Collaborate with cross-functional teams including Quality Assurance, Manufacturing, R&D, Regulatory Affairs, and Supply Chain.
• Support validation and qualification efforts for equipment, methods, and processes.
• Provide training, mentoring, and performance evaluations for QC personnel.
• Stay up to date with industry trends, regulatory updates, and best practices in tissue banking and medical device QC.
Qualifications:
• Bachelor’s degree in Biology, Chemistry, Life Sciences, Biomedical Engineering, or a related field (Master’s preferred).
• Minimum 2 years of QC experience in a regulated medical device, biotech, or tissue banking environment.
• At least 2 years of experience in a leadership or management role.
• Strong understanding of tissue banking regulations and standards (AATB, FDA HCT/P, etc.).
• Experience with laboratory techniques and instrumentation (e.g., sterility testing, endotoxin, environmental monitoring).
• Familiarity with LIMS, document control systems, and data integrity requirements.
• Excellent organizational, analytical, and communication skills.
• Ability to manage multiple projects and priorities in a fast-paced, regulated environment.
Preferred Qualifications:
• Certified Tissue Bank Specialist (CTBS) or similar certification.
• Experience working in a cGMP and ISO 13485 environment.
• Knowledge of cleanroom and aseptic processing requirements.
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