Quality Assurance Specialist for Sterilization Processes

hace 2 semanas


Tijuana, Baja California, México Stryker Tijuana Operations A tiempo completo
About the Role

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.
Requirements

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.
What We Offer

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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