Quality Engineer III

Quality Engineer III

Responsibilities

• Manage and coordinate the group of quality technicians designated for the mechanical tests required to product.
• Develop, generate, and communicate QMS metrics and Quality Department data to management and other stakeholders. 
• Facilitate customer related processes such as complaint handling, information inquiry, etc.
• Supports the efforts or tasks which need the Quality Department involvement or participation, including but not limited to nonconforming material handling, quality inspections, yield trending, etc.  
• Conduct, coordinate continuous improvement activities.
• Data analysis on key process indicator
• Assisting in ISO9001 internal audit activities
• Assisting on compliance verification during new project review
• Coordinate incoming inspection process for raw material
• Develop, execute and manage validation protocols such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
• Analyze and interpret test data to identify trends, resolve issues, and create compliance and validation reports.

Requirements:

• Bachelor’s Degree in Engineering or related discipline is required, with 3-5 years of experience in a manufacturing environment 
• 3 - 5 years' experience in Quality Control activities
• Knowledge and experience of using structured problem-solving methods such as 6M, 5Why, or other types of integrated problems solving and root cause analysis 
• Experience managing personnel 
• Knowledge and experience in documentation management function, including proficiency with MS Office, understanding engineering drawings & specifications, concept of controlled documents, information technology enhanced document control systems, etc.  
• Experience with SPC, MSA, FMEA and Control Plan 
• Must be able to utilize all hand tools, micrometers, optical comparator, and other related equipment with optimal accuracy.  
• Knowledge on Nitinol fundamentals
• Create and maintain detailed documentation for all validation activities, including test plans, reports, and risk assessments.
• Work with other departments, such as manufacturing, and quality assurance, to ensure the validation process meets business and regulatory needs.
• Ability to prepare and present quality reports and findings to management and other stakeholders in both languages.
• Full fluency (written and verbal) in both English and a spanish is mandatory.

Ubicación: Mexicali, Baja California