Sr. Manager Quality Assurance

The Senior Manager – QMS will lead the development, implementation, maintenance, and continuous improvement of the company’s ISO 13485-compliant Quality Management System across multiple manufacturing and support units. This role is critical to ensure consistent product quality, process efficiency, global regulatory compliance readiness, and a strong quality culture across the organization.

Key Responsibilities:

QMS Governance & Compliance

Lead the organization-wide implementation and maintenance of ISO 13485:2016, 21 CFR Part 820, Schedule V – MDR 2017, and MDSAP-aligned QMS.

Ensure all quality-related processes, documents, and records are compliant and audit-ready at all times.

Conduct and manage internal quality audits, gap assessments, and follow-up on CAPA execution.

Coordinate and prepare for external audits by regulatory bodies, notified bodie...