Quality & Reliability Engineer II

About the role

As a Quality & Reliability Engineer II at TE, you will apply your engineering expertise to ensure product quality and reliability across diverse manufacturing environments. You will work closely with cross‑functional teams and external customers to meet stringent regulatory and quality standards.

Key responsibilities

• Validate new equipment, products, and processes using IQ, OQ, PQ, SQ, TVM, and FMEA protocols.
• Prepare, execute, and analyze data for validation activities and generate detailed reports.
• Investigate customer, supplier, and internal non‑conformance complaints, perform root‑cause analysis, and verify corrective actions.
• Develop and maintain technical procedures, work instructions, and quality metrics.
• Train operators and engineers on validation and quality processes.
• Approve customer drawings for manufacturing use and ensure compliance with ISO 13485 and FDA regulations.
• Conduct internal audits and serve as liaison with external customers.

Required profile

• 1‑2 years of experience as a Quality Engineer or similar role.
• Bachelor’s degree in engineering, science, or a related field.
• Bilingual English (intermediate) and Spanish.
• Ability to work independently with minimal supervision.
• Strong written and verbal communication skills for technical documentation.

Required skills

• Minitab
• JMP
• Microsoft Office suite
• ISO 13485 knowledge
• FDA regulatory knowledge
• IQ/OQ/PQ/SQ/TVM validation protocols
• FMEA methodology
• Statistical data analysis
• Inventory and manufacturing software