Quality Engineer (Buffalo Grove)

The Quality Engineer will be maintaining quality engineering programs, standards, and improvements within the organization.

• Develops and initiates standards and methods for inspection, testing, and evaluation.
• Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.
• Develops and implements methods and procedures for the disposition of discrepant material and devises methods to assess cost.
• Directs workers engaged in measuring and testing products and tabulating data concerning materials, product, or process quality and reliability.
• Compiles and writes training material and conducts training sessions on quality control activities.
• Holds up Product Engineers and Quality Program Managers with customer interfaces as necessary on quality-related issues.
• Assures data availability and integrity for all quality-related data. Consolidates and reports quality results.
• Initiates corrective action requests as needed and tracks to satisfactory completion.
• Assists with the development and implementation of quality audits.
• In charge of developing, applying, revising, and maintaining quality standards for processing materials into partially finished or finished products.
• Designs and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and/or production equipment.
• Explores reports and returned products and recommends corrective action.
• Establishes a program to evaluate the precision and accuracy of production equipment and testing, measurement, and research of equipment and facilities.
• Approves product, process, and equipment qualifications.
• Provides liaison to various regulatory bodies.

Requirements

• Bachelor’s degree in a related field or equivalent experience
• 6 years of quality engineer experience
• 3+ years of medical device, Pharma, or Biotechnology industry experience
• ISO13485
• CAPAS, SCARS, NCMRs experience
• ISO/FDA certification (preferred)