Quality Engineer

Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a Quality Engineer, you will provide Quality Engineering input to support Medical Device Manufacturing, Manufacturing Engineering, Operations, and Distribution activities, and develop, establish, and maintain quality engineering methodologies, systems, and practices that meet Biomerics, customer, and regulatory requirements.

Requirements

• Bachelor's Degree in Engineering, Biomedical Engineering, or related science discipline.
• ASQ / CQE certifications
• Six Sigma Certified Green or Black Belt
• Minimum of 5 years' experience in Quality Engineering within a Medical Device Manufacturing environment.
• Working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, MDD/AIMDD, CMDR, JPAL medical device regulations;
• Experience in nonconforming material and CAPA methodologies/systems preferred
• Familiar with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent)