Senior Supplier Quality Engineer
Core
Establish supplier quality compliance, conduct audits and risk assessments, and lead corrective actions for suppliers in life sciences diagnostics.
Role type
Senior Supplier Quality Engineer
Builds
Molecular diagnostic systems and tests for global healthcare markets
Domain
Life sciences, diagnostics, biotechnology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Supplier process audits, supplier risk classification, supplier corrective action processes, supplier onboarding, supplier evaluations, manufacturing quality toolset (NCR, SCAR, MRB, PFMEA, IQ/OQ/PQ, GR&R, control plans, process validation, SPC, DOE, DMAIC), statistical process control, New Product Introduction (NPI), manufacturing process improvements, quality system enhancements, engineering and scientific analysis, DHF/DMR compliance
Preferred skills
FDA 21CFR820, ISO 13485, Certified Lead Auditor, Instrument Box Level, Injection Molding, Material Consumable experience
Technologies
NCR, SCAR, MRB, PFMEA, IQ, OQ, PQ, GR&R, SPC, DOE, DMAIC
Responsibilities
Establish quality compliance and proactive initiatives including supplier audits and risk classifications; Define and apply manufacturing quality toolset for process validation and control; Collaborate with product support and engineering on complex supplier quality issues and lead quality in NPI and sustaining projects
Seniority
Senior, hands-on IC
