Quality Engineer II
Core
Provide Quality Engineering support for manufacturing lines and New Product Introduction (NPI) activities, ensuring high-quality product delivery and supporting continuous improvement.
Role type
Quality Engineer II (Manufacturing)
Builds
Robust, high-quality medical devices and manufacturing processes
Domain
Medical device manufacturing
Required skills
Six Sigma, statistical analysis, Lean methodologies, root cause analysis, CAPA systems, process control, data analysis (Excel, Minitab), problem-solving
Preferred skills
ISO 13485, New Product Introduction (NPI), project management, regulated industry experience
Technologies
Excel, Minitab
Responsibilities
Identify and implement effective process control systems; drive enhancements to existing process controls; investigate and implement best-in-class Quality Engineering practices; promote quality assurance and CAPA systems; apply systematic problem-solving methodologies to resolve quality issues; collaborate with production teams to improve outgoing product quality; collect and analyze process defect data; lead initiatives to reduce manufacturing process defects; apply Six Sigma, statistical analysis, and Lean methodologies.
Seniority
Mid-level, hands-on IC