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 bodies, and cus...