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Quality Assurance Specialist

hace 2 meses


Tijuana, Baja California, México Bepc Inc A tiempo completo

Bepc Inc is seeking a skilled Validation Technician to join our team in Tijuana. This role is responsible for working on the shop floor to define the impact of variant parts and components, collaborating with associates, group leaders, and supervisors.

Key Responsibilities:
  • Develop and execute process validation protocols (IQ, OQ, PQ) and engineering change orders.
  • Write and approve changes to manufacturing documentation, including manufacturing work instructions, BOMs, routers, and travelers.
  • Troubleshoot process and equipment malfunctions, and assess process validations, software validations, and database updates.
  • Manage MGF-related ECOs (PI, MOPs, SOPs) and ensure compliance with regulatory requirements.
Requirements:
  • 1+ years of experience as a technician in a related field.
  • Excellent communication skills and advanced English proficiency.
  • Availability to travel and work in a fast-paced environment.
  • Experience with medical devices and manufacturing processes.