Manufacturing Quality Engineer - Howell, MI
Core
Independently set quality standards, develop testing methods, and manage vendor quality for medical device manufacturing processes.
Role type
Manufacturing Quality Engineer
Builds
Production processes, testing methods, and regulatory documentation (DMRs, 510K submissions)
Domain
Medical Devices / Manufacturing
Required skills
Statistical process control (SPC), experimental design, CAPA implementation, supplier quality management, regulatory compliance (21 CFR 820, ISO13485), risk management
Preferred skills
Medical device industry experience
Technologies
MS Office Suite (Excel, Word, PowerPoint, Outlook)
Responsibilities
Manage process control and validation methods; Design and perform product testing and analysis; Collaborate with suppliers on quality problems and corrective actions; Ensure compliance with domestic and international regulations; Lead investigations of non-conformances and develop CAPA
Seniority
Mid-level, hands-on IC