Taevas Life Sciences is looking for a highly driven Quality & Compliance Lead (Contractual) to establish, maintain, and enhance our Quality Management System (QMS) in line with ISO 13485 and global regulatory standards. This role will play a critical part in ensuring organizational compliance, audit readiness, and process excellence across operations.
Key Responsibilities
ISO 13485 QMS Implementation
Lead end-to-end implementation and maintenance of ISO 13485 QMS. Develop and maintain SOPs, quality manuals, and controlled documentation. Ensure alignment of quality processes across Regulatory, Supply Chain, and Service Delivery functions. Audit & Compliance Management
Plan and conduct internal audits. Prepare teams and documentation for external audits and certification activities. Drive CAPA management and closure of non-conformities. Quality Systems & Process Excellence
Establish and manage CAPA, change control, deviation handling,
and risk management processes aligned with ISO 14971. Maintain documentation control systems and ensure process standardization across global operations. Training & Quality Culture
Conduct training sessions on QMS and compliance requirements. Promote a strong culture of quality and continuous improvement across the organization. Preferred Profile
6–12+ years of experience in Quality Assurance / QMS. Hands-on experience implementing ISO 13485. Experience handling external audits and certification processes. Background in medical device manufacturing preferred. Robust process-oriented and documentation management mindset. If you are passionate about quality, compliance, and building scalable systems in the medical device industry, we would love to hear from you.