Design and Sustaining Quality Engineer
Core
Design and sustain quality engineering for NP Medical products and processes, ensuring compliance with quality systems and regulatory requirements.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Quality evaluation and control plans, inspection/testing protocols, and corrective action processes for medical device manufacturing.
Domain
Medical Device Manufacturing / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root Cause Analysis, Statistical Analysis, CAPA management, ISO 13485 compliance, Process Validation, Cross-functional leadership, Data-driven process improvement, Six Sigma methodologies
Preferred skills
Green Belt, Black Belt, CQE, Certified Auditor (ISO 13485), Power BI/Tableau/Looker
Technologies
Microsoft Office (Excel, Word, PowerPoint), BI tools (Power BI, Tableau, Looker), Plant Quality System software
Responsibilities
Develop and maintain quality evaluation and control plans; Design and analyze inspection/testing processes; Audit quality systems for deficiencies; Lead CAPA completion and documentation; Mentor less experienced Quality Associates; Support plant Quality System software validation.
Seniority
Senior, hands-on IC with mentoring responsibilities