Senior Quality Assurance Engineer

hace 4 semanas


Tijuana, Baja California, México Insulet Corporation A tiempo completo
Job Summary

Insulet Corporation is seeking a Quality Assurance Engineer II to ensure the safety and quality of our products and procedures through rigorous inspections, implementation of quality control measures, and identification of areas for improvement.

Key Responsibilities
  • Collaborate with cross-functional teams to address quality issues, drive continuous improvement, and contribute to building high-quality products that exceed customer expectations.
  • Develop and manage Quality Control Technicians, contribute to cost-saving and safety initiatives, and generate and maintain process requirements, specifications, validation, and confirming quality documents.
  • Develop and execute test method validations, develop and maintain FMEAs and Control Plans, and perform, maintain, and sustain activities under QMS.
  • Ensure that FI, CAPA, NMCRs, and Customer complaints are addressed in a timely manner, coordinate and/or contribute in DHRs processes, and document quality alerts and coordinate investigations.
  • Generate weekly and monthly reports using quality objectives, provide support during audits and/or customer visits, and participate in the performance of the environmental management system.
Requirements
  • Bachelor's degree in engineering (industrial, chemical, manufacturing, or any other related) and/or 3 years of QA/QC engineering work experience in medical device manufacturing processes.
  • Knowledge of risk management analysis, FMEA - Control Plans management, statistical data analysis on Minitab, preferable, Test Method validation and GR&R execution, root cause analysis techniques management, CAPA - Complaint - NCMR execution and management.
  • Experience in Lean and Kaizen participation and execution is preferred, negotiation and leadership skills, and advanced computer skills.


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