Quality Engineer: Lead QMS & NPD Improvements

Cicor Group; Solon (OH); On-site; USD 70,000 - 100,000; Full time

Job summary

Cicor Solon, OH is seeking a Quality Engineer to provide quality assurance support to the product development team and resolve defects to ensure customer specifications are met.

Responsibilities include maintaining ISO 13485 compliant processes, leading quality investigations, and ensuring regulatory compliance across manufacturing, NPD, and suppliers. Strong communication and cross-functional collaboration are essential.

Qualifications

• Higher education degree or 5 years work experience in lieu of degree.
• Medical Device experience required including knowledge of FDA regulations.
• Excellent written and oral communication skills.
• Prolonged periods of sitting at a desk and working on a computer.

Responsibilities

• Understand ISO 13485:2016 requirements (FMEA, CAPA, Root Cause Corrective Action).
• Create and maintain quality metrics and execute design controls.
• Lead quality investigations and CAPA activities.
• Support manufacturing and NPD to ensure regulatory compliance.
• Communicate across R&D, Manufacturing, Supply Chain and Customer Service.

Skills

Communication

Organization

Analytical thinking

Cross-functional collaboration

Problem solving

Education

Bachelor's degree or 5 years experience in lieu of degree

Tools

Microsoft Office

Excel

Word

PowerPoint

Job description

Cicor Solon, OH is seeking a Quality Engineer to provide quality assurance support to the product development team and resolve defects to ensure customer specifications are met.

Responsibilities include maintaining ISO 13485 compliant processes, leading quality investigations, and ensuring regulatory compliance across manufacturing, NPD, and suppliers. Strong communication and cross-functional collaboration are essential.