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Stryker | Senior Manager, Quality Assurance

hace 4 semanas


baja california, México Stryker A tiempo completo

Work Flexibility: Onsite

What you will do

  • Oversee the implementation and maintenance of the Quality Management Systems to ensure compliance with FDA, ISO 13485, and other applicable regulations and standards. Act as a Management Representative for Tijuana Sterilization Site operations if needed.
  • Lead and develop the Quality Operations team, ensuring training, performance management, and fostering a culture of inclusiveness, trust, and teamwork.
  • Collaborate with site leadership, global quality teams, and operational partners to align quality objectives with business strategies and leverage resources effectively.
  • Ensure site accreditation with regulatory rules, manage internal and external audits, and maintain compliance with quality standards, including risk management and CAPA processes.
  • Drive quality improvement initiatives to enhance product quality, reduce costs, and improve efficiency, including implementing automation and other quality projects.
  • Lead root cause analyses and mentor CAPA owners to ensure thorough investigations, action plans, and effective implementation of corrective actions.
  • Support Post-Market Surveillance activities, including Medical Device Reporting (MDR), and provide timely reporting on trends and QMS performance.
  • Partner with internal and external stakeholders to ensure timely resolution of non-conformances and share best practices across sites.
  • Ensure the organization meets or exceeds customer requirements and regulatory expectations through effective quality planning and execution.
  • Provide regular updates to leadership on quality performance, nonconformance management, and process improvement efforts.
  • It will be required to work in hazardous areas and pass the initial and subsequent medical surveillance (total blood cell counts, pulmonary functional test, Chest X Rays) and require wearing respiratory protection (SCBA).

What you will need

  • Bachelor’s degree in a scientific, engineering or clinical discipline.
  • At least 7 years work experience in Quality Assurance in a medical device manufacturing environment.
  • Experience with FDA and international Quality System rules, regulations, including planning and implementation.
  • 3 to 5 years’ experience in managing technical personnel and complex activities.
  • Fluent in both Englishand Espanish required.
  • Quality Systems knowledge (QSR, ISO 13485: 2016, MDD).
  • Certified Auditor.
  • Six Sigma Green Belt or Black Belt.
  • Proficient in Microsoft Word, Excel, Power Point, Outlook.
  • Systems knowledge is a plus (MES, SAP, onePLM, Trackwise, Valgenesis among others).
  • Database Management and Statistical software (e.g. MiniTab) is recommended.
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