Quality Project Leader: Drive GMP Excellence & Compliance

Socket.dev; Buffalo Grove (IL); On-site; USD 120,000 - 140,000; Full time

Job summary

Nemera is seeking a Quality Project Manager to assure high quality products and services that satisfy customer and regulatory requirements. You will lead the Quality Department, drive CAPA activities, manage validations, and coordinate cross-functional teams to close gaps and improve process efficiency.

The role requires a Bachelor's degree in Engineering, 4+ years of manufacturing quality experience, and strong English communication. Travel between offices and production sites is expected.

Qualifications

• Bachelor’s degree in Engineering or related field is required.
• 4+ years of quality experience in manufacturing with supervisory experience.
• Strong communication skills in English.
• Knowledge of ISO, cGMP, FDA, and Health & Safety requirements.
• Experience with injection molding, automation, and FMEA.

Responsibilities

• Assist Associate Director of Quality in coordinating goals to improve product quality and efficiency.
• Direct and coordinate activities of Quality Department staff.
• Lead CAPA activities and drive root cause analyses.
• Manage process and equipment validations for new and existing products.
• Represent Quality in audits and ensure regulatory compliance.

Skills

Communication

Leadership

Problem solving

Teamwork

Attention to detail

Education

Bachelor’s degree in Engineering or related field

Tools

SAP

Excel

Database software

Job description

Nemera is seeking a Quality Project Manager to assure high quality products and services that satisfy customer and regulatory requirements. You will lead the Quality Department, drive CAPA activities, manage validations, and coordinate cross-functional teams to close gaps and improve process efficiency.

The role requires a Bachelor's degree in Engineering, 4+ years of manufacturing quality experience, and strong English communication. Travel between offices and production sites is expected.