Manufacturing Quality Engineer - Mankato, MN
Core
Independently set quality standards, develop testing methods, and ensure compliance with regulations for medical device manufacturing processes.
Role type
Manufacturing Quality Engineer
Builds
Production processes, testing methods, and regulatory documentation for medical devices
Domain
Medical Devices / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Statistical process control (SPC), experimental design, root cause analysis, CAPA development, supplier quality management, regulatory compliance (21 CFR 820, ISO13485), MS Office Suite
Preferred skills
Medical device industry experience, drug industry experience
Technologies
MS Office Suite (Word, Excel, PowerPoint, Outlook)
Responsibilities
Manage development and implementation of process control and validation methods; Design experiments to analyze variation and evaluate process changes; Direct collaboration with suppliers on quality problems and corrective actions; Provide expertise in Product Development, Design Control, and Risk Management; Coordinate product testing with internal and external laboratories; Lead investigations of non-conformances and develop corrective actions
Seniority
Mid-level, hands-on IC