Experience Requirement - Minimum 8-10 years of experience in Quality Control in a regulated medical device manufacturing environment, Minimum 2–3 years in a leadership or managerial role.
1. Leadership and Team Management
Lead, mentor, and manage the QC team.
Conduct performance reviews, provide training, and foster professional development.
Establish goals and KPIs for the QC function to ensure efficiency, accuracy, and accountability.
2. Inspection & Testing Oversight
Develop and enforce procedures for incoming material inspection , in-process testing , and final product release.
Ensure proper operation and calibration of testing equipment and tools.
Implement statistical sampling plans and quality control techniques (e.g., AQL, SPC).
3. Compliance & Regulatory Alignment
Maintain compliance with global regulatory standards (FDA, ISO 13485, MDSAP, EU MDR, etc.).
Ensure product release criteria are consistently applied and documented.
Manage QC-relat...