Senior Manager, Quality Assurance Management (Costa Rica)

Job Summary (Confidential)

The Senior Manager, Quality Assurance is responsible for leading and managing all MEVS Quality Assurance activities at the manufacturing site to ensure compliance with applicable regulatory requirements (including but not limited to 21 CFR 820, ISO 13485, ISO 13408, EU MDR, MDSAP), as well as internal policies and industry standards.
This role is critical to maintaining product quality, patient safety, continuous improvement, and regulatory compliance for the MEVS.

Essential Functions & Accountabilities

• Provide QA oversight for MEVS manufacturing processes, including operations, formulation, packaging, and finished goods release.
• Oversee and, as needed, participate in day-to-day QA activities including DHR review and approval, NCMR, CAPA, document control, product release, and ECN processes for the MEVS.
• Write, review, and approve Standard Operatin...

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