Manufacturing Quality Engineering
Core
Provide technical leadership to production teams, drive quality and process improvements, and ensure regulatory compliance in a regulated medical technology manufacturing environment.
Role type
Manufacturing Quality Engineer
Builds
Safe, compliant, and efficient manufacturing operations for medical technology products
Domain
Medical device manufacturing / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
root cause analysis, continuous improvement methodologies, risk management, validation planning, audit execution, CAPA management, regulatory compliance knowledge, Lean Manufacturing, process validation, equipment implementation
Preferred skills
Six Sigma, project management, matrix organization experience, ambiguity management, best practice implementation
Technologies
ISO 13485, FDA Quality System Regulations, GMP, Electronic Records, Electronic Signatures, Device Master Records, Device History Records
Responsibilities
Drive continuous improvement initiatives focused on product quality and cost efficiency; Lead investigations related to non-conformances, complaints, and CAPAs; Plan and perform internal quality audits and support external regulatory inspections; Lead validation and verification activities for manufacturing processes and equipment; Provide daily technical support to production teams regarding methods, tooling, and processes.
Seniority
Mid-level, hands-on IC
