Principal Quality Management Systems Specialist, Sterilization

What you will do Ensure compliance and maintenance of the Quality Management System (QMS) at the Stryker Sterilization facility in Tijuana, Mexico.
Act as a subject matter expert on FDA Quality System Regulation, MDSAP regulations, ISO 11135, and ISO 13485 standards.
Support internal and external quality system audits, ensuring compliance.
Lead investigations, manage non-conformances (NC), and perform CAPA review and approval tasks.
Develop and maintain Power BI dashboards related to the QMS, in collaboration with Corporate RAQAC analytics.
Train new QMS specialists on Stryker's procedures and sterilization quality management systems.
Plan and execute internal audits based on the processes of the sterilization organization.
Coordinate and provide applicable compliance training.
Interpret and apply regulations such as FDA, ISO, MDSAP, EU MDR, and Stryker policies.
Conduct trend analysis on key performance indicators and organize Management Reviews.
What you need BS in a science, engineering, or related discipline. Master's degree or equivalent preferred.7+ years of similar experience in a high regulated industry.Exerience with the following regulations/standards preferred: 21 CFR Part 820, MDSAP, ISO standards (e.g., ISO 13485:2016, ISO 14971:2019) and ISO 11135 – Ethylene Oxide Sterilization.Solid knowledge of manufacturing processes, statistical techniques, environmental controls and basic Regulatory requirements for medical devices.Strong knowledge of quality management system processes (NC/CAPA, Complaints Handling, Management Review, Quality Planning, etc.).Bilingual (English & Spanish).Utilize proper software to maintain project records, MS Office, SharePoint, Visio and Power BI.

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