Senior Quality Engineer (Onsite)
Core
Ensuring process integrity and product performance for patient-specific temporomandibular joint prostheses in a regulated manufacturing environment.
Role type
Senior Quality Engineer (Medical Device Manufacturing)
Builds
Custom patient-specific implants (TMJ prostheses)
Domain
Medical device manufacturing / Regulated environment
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
root cause investigation, statistical process control, change management, audit support, KPI monitoring, material disposition, process validation, risk management
Preferred skills
Six Sigma Green/Black Belt, ISO 13485 knowledge, advanced statistical methods
Technologies
None explicitly stated
Responsibilities
Monitor and improve product and process quality performance using KPIs and trend analysis; Own non-conformances and corrective and preventive actions; Disposition non-conforming product in material review processes; Evaluate and approve manufacturing and supplier change requests; Support internal and external audits; Apply statistical methods to assess variation and improve capability
Seniority
Senior, hands-on IC