Confluent Medical is seeking a Senior Staff Quality Assurance Engineer who will lead problem-solving and improvement projects, focusing on quality standards and validation processes in manufacturing. The role requires extensive experience in quality systems, particularly in the medical device industry, along with strong analytical and leadership skills
Job Summary
The role involves leading problem-solving projects and providing technical guidance on complex manufacturing improvements.
Responsibilities include developing validation protocols, conducting audits, and managing risk assessments like PFMEA for medical products.
The position requires supervising teams and ensuring compliance with federal, state, and company regulations for health and safety.
Matching Summary
Match Score: 85
Confluent Medical is seeking a Senior Staff Quality Assurance Engineer who will lead problem-solving and improvement projects, focusing on quality standards and validation processes in manufacturing. The role requires extensive experience in quality systems, particularly in the medical device industry, along with strong analytical and leadership skills.
Skills & Requirements
Must-have
Bachelor degree in engineering discipline
6-7 years manufacturing process experience
Process validation and software validation
Risk management (PFMEA) development
CAPA and complaint investigation
Basic statistics and Minitab proficiency
Nice-to-have
Certified Quality Engineer (CQE)
Six Sigma Black Belt certification
ISO13485 lead auditor certification
Internal auditor experience
Medical device industry background
Key Requirements
Bachelor degree in related engineering discipline
6-7 years of combined manufacturing and quality systems experience