El Paso - Quality Assurance Analyst

Responsibilities

• Develop, implement, and maintain quality management systems (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory standards for medical devices
• Conduct internal audits and support external audits to ensure adherence to quality policies, procedures, and regulatory requirements
• Review and approve batch records, deviations, change controls, CAPAs, and other quality documentation to ensure accuracy and completeness
• Collaborate cross-functionally with R&D, manufacturing, and regulatory affairs teams to drive continuous quality improvement initiatives
• Investigate customer complaints and non-conformances, performing root cause analysis and implementing corrective and preventive actions
• Monitor quality metrics and KPIs, preparing reports and presenting findings to leadership to support data-driven decision-making
• Ensure product testing, inspection, and release activities meet established specifications and global quality standards

About the Company

A global leader in medical technology, this organization develops, manufactures, and sells a broad portfolio of medical supplies, devices, laboratory equipment, and diagnostic products. With operations spanning more than 190 countries, the company is committed to advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. Their India operations serve as a critical hub for manufacturing, R&D, and quality innovation, supporting both domestic healthcare needs and global supply chains. The organization is deeply focused on patient safety, regulatory excellence, and sustainable business practices.

About Caliber

Caliber is a specialized staffing and recruiting firm dedicated to connecting top talent with leading organizations across a variety of industries. With a commitment to understanding both client needs and candidate strengths, Caliber delivers tailored workforce solutions that drive measurable results. Their experienced team of recruiters brings deep industry knowledge and a consultative approach to every search, ensuring the right fit for both employer and employee. Caliber takes pride in building long-term partnerships rooted in trust, integrity, and exceptional service.