Senior Sterilization Quality Management Specialist
hace 3 semanas
At Stryker Tijuana Operations, we are seeking a Senior Sterilization Quality Management Specialist to ensure compliance and maintenance of our Quality Management System (QMS) at our sterilization facility in Tijuana, Mexico.
The selected candidate will act as a subject matter expert on FDA Quality System Regulation, MDSAP regulations, ISO 11135, and ISO 13485 standards, supporting internal and external quality system audits and ensuring compliance.
The role involves leading investigations, managing non-conformances (NC), and performing CAPA review and approval tasks, as well as developing and maintaining Power BI dashboards related to the QMS in collaboration with Corporate RAQAC analytics.
The ideal candidate will have a BS in a science, engineering, or related discipline, a strong knowledge of quality management system processes, and experience with the mentioned regulations and standards.
Additionally, the candidate should have solid analytical and problem-solving capabilities, strong communication, project management, and influencing skills, as well as bilingual capabilities (English & Spanish).
We offer a dynamic work environment with opportunities for growth and development.
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Tijuana, Baja California, México Stryker Tijuana Operations A tiempo completoJob Description:Stryker Tijuana Operations is seeking a highly skilled Quality Assurance Specialist to join our team in Mexico. As a key member of our sterilization operations team, you will be responsible for ensuring compliance and maintenance of our Quality Management System (QMS).Key Responsibilities:Ensure adherence to FDA Quality System Regulation,...
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