Senior Advanced Quality Engineer
Core
Lead Quality Engineering activities to ensure product and process quality for new product development, providing guidance on compliance to quality systems and external standards.
Role type
Senior Advanced Quality Engineer (Medical Device)
Builds
New medical device products compliant with regulatory standards
Domain
Medical Device Industry / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk management, Design verification and validation, Statistical analysis, Root cause analysis, Regulatory compliance (FDA, MoH, TUV), CAPA management, Inspection planning, CAD drawing interpretation, Cross-functional collaboration
Preferred skills
Six Sigma Green or Black belt, MS degree, CQE or CRE certification, Medical device product development lifecycle experience, Advanced Quality tools (FMEA, GD&T, Mistake Proofing/Poke Yoke)
Technologies
Mini-Tab, CAD software
Responsibilities
Develop quality assurance documentation for regulatory submissions, Engage in design reviews to identify and mitigate risks, Support definition and completion of design verification and validation reports, Analyze critical quality attributes through risk analysis, Lead risk management activities including developing risk plans and conducting reviews, Support product design transfers to manufacturing facilities, Evaluate predicate products for quality issues, Participate in collecting initial market feedback
Seniority
Senior, hands-on IC
