Sr. Quality Engineer
Core
Setting quality standards, validating processes, and ensuring regulatory compliance for medical device manufacturing and product development.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Production processes, validated testing methods, regulatory submissions (510K), and quality documentation.
Domain
Medical Devices / Manufacturing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Statistical Process Control (SPC), experimental design, risk management, CAPA development, supplier quality management, regulatory compliance (21 CFR 820, ISO13485), MS Excel (advanced), cross-functional leadership
Preferred skills
Six Sigma/Lean concepts, 5+ years in Medical Devices/Drugs
Technologies
MS Office Suite (Word, Excel, PowerPoint, Outlook)
Responsibilities
Manage development of process control and validation methods; Design complex experiments to analyze process variation; Lead supplier qualifications and corrective actions; Build product documentation (Device Master Records) for regulatory submissions; Investigate non-conformances and develop CAPA; Coordinate product testing with internal and external laboratories.
Seniority
Senior, hands-on IC with team leadership