Manager, Quality

Job Summary: The Quality Manager in the field of Medical Manufacturing plays a critical role in ensuring the highest standards of quality, compliance, and regulatory adherence across all aspects of the manufacturing process. This leadership position requires expertise in quality management systems, regulatory requirements, and continuous improvement methodologies. The Quality Manager is responsible for establishing and maintaining a culture of quality excellence while ensuring the safety and efficacy of medical products.

Duties & Responsibilities

1. Quality Management System

• Develop, implement, and manage a robust quality management system (QMS) compliant with applicable regulations such as ISO 13485 and FDA guidelines.
• Ensure that all manufacturing processes and procedures adhere to the established QMS.

2. Regulatory Compliance

• Stay current with medical device regulations, standards, and guidelines to en...