Senior Staff Quality Engineer
Stryker • Grecia, Costa Rica
Role Description
**Description:**
As a Senior Staff Quality Engineer, you will play a key role in ensuring the effectiveness of the Quality Management System (QMS) and compliance with applicable regulatory standards such as FDA GMP, ISO 13485, and MDSAP.
This role is critical in maintaining product quality, minimizing risks, and supporting continuous improvement initiatives across manufacturing and engineering processes. You will collaborate cross-functionally to resolve quality issues, enhance processes, and ensure compliance with both internal and external requirements, ultimately safeguarding product integrity and customer trust.
**Responsabilities:**
+ Lead the identification, escalation, and resolution of quality issues, ensuring effective collaboration across Quality, Engineering, and Production teams.
+ Drive Nonconformance (NCR) and CAPA investigations, including root cause analysis, risk assessments, and implementation of corrective and preventive actions...
As a Senior Staff Quality Engineer, you will play a key role in ensuring the effectiveness of the Quality Management System (QMS) and compliance with applicable regulatory standards such as FDA GMP, ISO 13485, and MDSAP.
This role is critical in maintaining product quality, minimizing risks, and supporting continuous improvement initiatives across manufacturing and engineering processes. You will collaborate cross-functionally to resolve quality issues, enhance processes, and ensure compliance with both internal and external requirements, ultimately safeguarding product integrity and customer trust.
**Responsabilities:**
+ Lead the identification, escalation, and resolution of quality issues, ensuring effective collaboration across Quality, Engineering, and Production teams.
+ Drive Nonconformance (NCR) and CAPA investigations, including root cause analysis, risk assessments, and implementation of corrective and preventive actions...