Abbott
Lead and develop the Quality Release team, ensuring workload coordination, performance oversight, and procedural compliance. Review and approve DHRs, batch records, CoCs, and related documentation in accordance with GDP and regulatory standards. Ensure accurate product status updates in quality/ERP systems and escalate documentation or product discrepancies. Support regulatory compliance efforts, including audits and change controls related to product relea...
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Sr Quality Release Engineer - Queretaro Site
Description
The Opportunity
This role ensures that all medical devices are released in full compliance with applicable regulatory requirements (ISO 13485, 21 CFR Part 820, NOM-241), internal procedures, and customer specifications. The individual oversees the documentation review process, manages the Quality Release team, drives continuous improvement initiatives, and serves as the primary decision-maker for nonconformities related to final product documentation.
What You’ll Do