The Director of Quality Assurance / Quality Control (DQA / QC) supports the mission, goals, and strategic plan of Surgenex.The DQA / QC, will oversee donor chart quality assurance, quality control, while promoting organizational performance improvement. This includes developing, implementing, and monitoring the quality system to ensure regulatory compliance and the achievement of departmental and organizational goals. The role requires management of teams and processes in a fast paced environment that demands quick thinking, adaptability, and a proactive mindset.
About us : SURGENEX® is a privately held biotechnology company and accredited Tissue Bank by the AATB. Our company is headquartered in Scottsdale, Arizona. We develop, manufacture, and distribute the highest quality tissue allograft in the industry to accounts within the United States.
Key Responsibilities
Regulatory and Accreditation Compliance
- Ensure compliance with all relevant regulatory standards and industry accreditations, including FDA , AATB , and Surgenex-specific procedures.
- Assist in maintaining current licenses , registrations , and accreditations with regulatory bodies.
- Act as the primary liaison during audits , inspections , and surveys , ensuring regulatory requirements are met.
- Assist with the creation, revision, and maintenance of standard operating procedures (SOPs) for deceased and living donor tissue to ensure adherence to local , state , federal , and international standards.
Quality Assurance and Quality Control
Oversee the daily activities of the QA / QC team , ensuring compliance with the Quality Management System (QMS) . This includes :Reviewing donor eligibility charts and tissue inspection processes.Ensuring accurate label generation and proper tissue preparation for irradiation .Collaborating during root cause analysis for occurrence reporting investigations and leading corrective and preventive actions.Manage the QA / QC production record review process to ensure completeness and accuracy of donor and processing records , ensuring timely identification and correction of deficiencies.Implement an efficient process for the review and completion of pending lists and work closely with partner agencies on aging donor records and key performance indicators (KPIs).Collaborate and communicate effectively with affiliated partners to ensure smooth operations related to donor records and processing .Staff Management and Development
Directly manage QA / QC middle management and personnel , providing daily supervision , training, scheduling, and performance evaluations.Ensure staff understands their responsibilities and expectations and provide timely feedback when those expectations are not met. Apply disciplinary action when necessary.Promote employee mentoring and coaching through Performance Improvement Plans (PIP) , ensuring staff development and accountability.Lead recruitment, hiring, and training of new personnel, ensuring that the QA / QC team is well-equipped to meet quality standards.Documentation and Data Management
Ensure document control processes, including managing planned deviations , audits , equipment monitoring , and validations .Lead the development and delivery of routine QA / QC reports to the CQRO and Surgenex management.Use data analysis to identify opportunities for improvement (OFI) and present findings to the management team.Regulatory Guidance and Medical Oversight
Provide support as the donor eligibility advisor on-call, advising on complex eligibility determinations.Communicate with Surgenex medical directors , ensuring records are provided for final eligibility determinations .Seek guidance from the medical director on medical-related questions and eligibility concerns when needed.Continuous Improvement and External Relations
Attend industry-related workshops, meetings, and training sessions to stay current with regulatory standards and quality assurance practices .Establish and maintain positive relationships with internal and external customers, partners, and stakeholders.Uphold patient, donor, and company confidentiality at all times, ensuring ethical conduct in all operations.Strategic Planning and Performance Metrics
Assist in developing and maintaining departmental strategic plans , including employee and department KPIs and performance metrics .Collaborate on departmental objectives and track progress against established goals
