Supplier Quality Engineer II, Process Validations & Test Methods
Core
Lead supplier part qualification, process validations, and test method development to ensure critical component quality for medical device product development and commercial launch.
Role type
Supplier Quality Engineer II (Process Validations & Test Methods)
Builds
Critical components for Transcatheter Mitral & Tricuspid Therapies (TMTT) devices
Domain
Medical Device / Highly Regulated Industry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Supplier quality management, process validation (IQ/OQ/PQ), test method development, statistical analysis (Gage R&R, SPC, Process Capability), FMEA development, root cause analysis, GD&T interpretation, manufacturing process knowledge (injection molding, extrusion, machining), regulatory standards knowledge (FDA 21 CFR Part 820, ISO13485, ISO9001)
Preferred skills
Design controls expertise, optical measurement equipment operation, SolidWorks fixture design, Six Sigma tools proficiency, cross-functional negotiation
Technologies
SolidWorks, optical measurement equipment
Responsibilities
Facilitate gage studies and process capability studies, develop and validate test methods and inspection routines, conduct on-site supplier audits, manage supplier non-conformances and corrective actions, support component specification development, communicate quality risks to management
Seniority
Mid-level IC (2+ years experience or Master's degree)