Job Overview

A Quality & Reliability Engineer II uses their engineering skills to assist in issues related to the Quality of the product. This job also involves leveraging advanced technical skills to resolve issues related to the product to meet quality goals. 

Job Requirements

• Apply problem-solving techniques. 
• Apply geometry, fractions, percentages, ratios and measurements to resolve 
problems. 
• Leadership to administrative and manufacturing processes and people. 
• Working with employees from diverse cultures. 
• Apply excellent technical procedure writing skills in reports for products (Minitab, 
Computer skills). 
• Apply the knowledge in ISO 13485 and FDA regulations. 
• Ability to work independently with little or no supervision.

• Validate new equipment, products, or processes. Prepare, execute and analyze data for IQ, OQ, PQ, SQ, TVM, and FMEAs protocols and reports. 
• Train operators and engineers in validation activities. 
• Investigate customer, supplier, and internal non-conformance complaints. Perform root cause investigations, determine corrective action, and verify effectiveness. 
• Develop/analyze statistical data and product specifications to determine  manufacturing quality standards. 
• Approve customer drawings for use in manufacturing. 
• Create and modify current procedures and instructions. 
• Prepare/present technical Information and quality metrics to team members,  customers and management. 
• Serve as a professional liaison with external customers. 
• Maintain working knowledge of government and industry quality assurance  standards. 
• Develop internal audits to ensure compliance with applicable standards/regulatory requirements and organizations and ISO. 
• All other duties as assigned. 
• Supervision of Quality Engineers I.

What your background should look like

•  1-2 years of experience in similar positions (Quality Engineer I). Quality leadership experience working in a manufacturing environment, ideally in a multi-national environment. 
•  Bachelor’s Degree with a scientific or engineering emphasis.
•  Language: Bilingual English (Intermediate) / Spanish.
• Knowledge of Microsoft Office.
• Knowledge of problem-solving techniques.
• Fundamental understanding of geometry, fractions, percentages, ratios and 
  measurements.
• Thorough understanding of administrative and manufacturing processes.
• Interpersonal skills and adaptability working with employees from diverse cultures.
• Ability to read/interpret procedural materials such as job travelers, blueprints, sketches and diagrams.
• Excellent technical procedure writing skills, and inter-departmental verbal and written communication skills.
• Expert in the application of inferential statistics (Minitab, JMP).
• Previous experience working with a driven standard (ISO 13485, FDA, etc.).
• Computer skills with inventory and manufacturing software, order processing systems, spreadsheets, and word processors. 

Competencies