Quality Engineer

Avalign Technologies • Fort Wayne, IN

34d

About The Position

The Quality Engineer is responsible for supporting the organization to ensure quality and production goals are met. The Quality Engineer will utilize an engineering approach to improve manufacturing efficiencies and ensure quality standards of all products are met. What You’ll Do: Serves as a quality representative to assigned manufacturing areas and/or customers. Responsible for ensuring compliance with Avalign procedures, customer requirements; and industry regulations, including FDA Quality System Regulation and ISO 13485. Supports operations and engineering teams to ensure the Material Review Board process is followed. Provides ongoing quality engineering support to operations, including risk management, developing appropriate inspection requirements; and complaint/NC/CAPA investigations. Submit documentation to customers for new product launches and legacy product documentation requests.

Requirements

• Candidates should have a BS in an engineering science plus 0--3 years of manufacturing experience, or an equivalent combination of education and experience.
• Ability to utilize statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.

Responsibilities

• Serves as a quality representative to assigned manufacturing areas and/or customers.
• Responsible for ensuring compliance with Avalign procedures, customer requirements; and industry regulations, including FDA Quality System Regulation and ISO 13485.
• Supports operations and engineering teams to ensure the Material Review Board process is followed.
• Provides ongoing quality engineering support to operations, including risk management, developing appropriate inspection requirements; and complaint/NC/CAPA investigations.
• Submit documentation to customers for new product launches and legacy product documentation requests.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level