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 ri...