Quality Management Systems Specialist

hace 2 semanas

Tijuana, Baja California, México Stryker Tijuana Operations A tiempo completo

Job Summary

Stryker Tijuana Operations is seeking a highly skilled Quality Management Systems Specialist to join our team. As a key member of our sterilization facility, you will be responsible for ensuring compliance and maintenance of our Quality Management System (QMS).

Key Responsibilities

  • Ensure compliance and maintenance of the 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.

Requirements

  • BS in a science, engineering, or related discipline. Master's degree or equivalent preferred.
  • 7+ years of similar experience in a high regulated industry.
  • Experience 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).
  • Strong communication, project management and influencing skills.
  • Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.
  • Demonstrated ability to make timely and sound decisions through effective approaches for choosing a course of action or developing appropriate solutions.
  • Utilize proper software to maintain project records, MS Office, SharePoint, Visio and Power BI.

Travel Percentage

10%

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