Quality Assurance Specialist for Sterilization Processes
hace 2 semanas
Stryker Tijuana Operations is seeking an experienced Quality Assurance Specialist to join our team in Tijuana, Mexico. As a key member of our quality management system, you will be responsible for ensuring compliance with FDA regulations, MDSAP standards, and ISO 13485.
Key Responsibilities- Lead quality system audits, investigations, and corrective actions to ensure compliance with regulatory requirements.
- Develop and maintain Power BI dashboards to track key performance indicators and support data-driven decision making.
- Train new quality 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.
To be successful in this role, you will need:
- Bachelor's degree in a science, engineering, or related field; master's degree or equivalent preferred.
- At least 7 years of experience in a high-regulated industry, preferably with knowledge of FDA, ISO, and MDSAP regulations.
- Solid understanding of manufacturing processes, statistical techniques, environmental controls, and basic regulatory requirements for medical devices.
- Strong knowledge of quality management system processes, including NC/CAPA, Complaints Handling, Management Review, and Quality Planning.
- Bilingual (English & Spanish).
- Excellent communication, project management, and influencing skills.
- Ability to analyze complex data quickly and make timely decisions.
We offer a competitive salary of $120,000 - $150,000 per year, depending on experience, as well as a comprehensive benefits package, including health insurance, retirement plan, and paid time off. The travel percentage for this role is approximately 10%.
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