Senior Quality Engineer
Core
Ensuring quality of membrane products and medical devices by facilitating cross-functional execution of the Quality Management System (QMS), setting inspection processes, and identifying statistical trends.
Role type
Senior Quality Engineer (Regulated Manufacturing)
Builds
Membrane products and medical devices for life sciences, diagnostics, and biotechnology
Domain
Life sciences / Medical devices / Regulated manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management System (QMS) execution, root cause analysis (8D, DMAIC, fishbone), process validation (IQ/OQ/PQ, SPC), risk management (PFMEA, ISO 14971), cross-functional collaboration, regulatory compliance (ISO 9001/13485)
Preferred skills
Lean principles, Six Sigma Green Belt, Certified Quality Engineer (CQE), high-volume manufacturing experience
Technologies
8D, DMAIC, Fishbone analysis, IQ/OQ/PQ, SPC, PFMEA, ISO 14971
Responsibilities
Provide strategic quality oversight for manufacturing operations, lead complex root cause investigations and remediation efforts, direct process validation and control strategies, apply risk-based approaches to mitigate process risks, collaborate cross-functionally to drive continuous improvement initiatives
Seniority
Senior, hands-on IC
