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Hi - Quality Engineer

hace 3 meses

Mexicali, Baja California, México Sonova A tiempo completo
y detalle de las actividades

  • Support QA department on defining and scheduling internal audit calendars and frequencies based on risk level of the processes and communicate the dates to the stakeholders, as well as supporting on external audits.
  • Lead and support the audit preparation and execution, trend analysis, root cause analysis and implementation of corrective actions.
  • Develop solutions to identified problems and coordinate multidisciplinary team members to achieve the goals in timely and effectively manner.
  • Use of quality and continuous improvement tools and methodologies for problem solving (Ishikawa, DOE, DMAIC, 8D, Pareto, Histogram, etc.)
  • Support risk management, operations and assure documentation and procedures are followed, updated and maintained as required by internal Quality Policies and related FDA/cGMPs guidelines.
  • Lead in the identification and completion of NC and CAPA activities, including CAPA investigations and coach owners to ensure the effective and smooth implementation of the changes.
  • Ensure compliance with applicable regulatory requirements, such as FDA, ISO, and other relevant standards.
Experiência y requisitos

1+ year in Quality Engineer position. English - Professional Working Proficiency (Equivalent to 80%+, CEFR B2/C1). Intermediate proficiency on MS Word, Excel, Powerpoint, Outlook. Statistical and trend analysis technique.

Número de vacantes 1

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