Quality Assurance and Regulatory Leader, Medical Devices

Company Description

INCELL Corporation is a medical device and biotechnology company focused on innovative products that support advanced healthcare solutions. The organization emphasizes high-quality manufacturing practices, regulatory compliance, and continuous improvement across its product portfolio. Team members collaborate in a science-driven environment that values integrity, patient safety, and operational excellence. The company offers opportunities to contribute to meaningful work that impacts patient care, while supporting professional growth and cross‑functional collaboration.

The Quality Assurance and Regulatory Leader, Medical Devices is a full‑time, on‑site role based in San Antonio, TX. This role oversees the quality management system for medical devices, ensuring compliance with applicable regulations, standards, and internal procedures. Day‑to‑day responsibilities include developing, maintaining, and improving quality assurance processes; leading and coordinating internal and external quality audits; and ensuring adherence to Good Manufacturing Practices (GMP) throughout production and testing activities.

The leader will review and approve quality documentation, support risk management and change control, and collaborate with cross‑functional teams in R&D, manufacturing, and regulatory affairs to address nonconformances and implement corrective and preventive actions. This position also supports regulatory submissions, prepares quality and compliance reports for leadership, and provides training and guidance to team members on quality and regulatory requirements.

• Demonstrated expertise in current Quality Control and Quality Assurance, including monitoring product quality and implementing corrective actions.
• Strong background in Quality Management, with experience designing, maintaining, and improving quality management systems for medical devices, cell and tissue derived products.
• Hands‑on experience with Good Manufacturing Practice (GMP) in a regulated environment, ensuring compliant production and documentation practices.
• Proficiency in QMSR, Quality Auditing, including planning, conducting, and responding to internal and external audits.
• In‑depth knowledge of medical device regulations and standards (e.g., FDA 21 CFR 820, ISO 13485) and familiarity with risk management and 510(k) product development processes.
• Proven ability to lead cross‑functional teams, manage complex projects, and drive continuous improvement initiatives.
• Excellent analytical, problem‑solving, and communication skills, with attention to detail and strong documentation practices.
• Bachelor’s degree in engineering, life sciences, quality management, or a related field; advanced degree or relevant certifications (e.g., CQE, CQA, RAC) are a plus.
• Prior experience in medical device or biotech manufacturing environments, with responsibility for quality and regulatory compliance.