Design Assurance Engineer (f/m/d)
Core
Ensuring quality for new product implementation, manufacturing transfers, and QA projects in life sciences and diagnostics.
Role type
Design Assurance Engineer
Builds
New product introductions (NPIs), manufacturing transfers, and quality systems for medical devices and pharmaceuticals.
Domain
Life sciences, diagnostics, biotechnology, medical devices, pharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
QA process knowledge, design change control, document change control, process verification and validation, manufacturing process control, Six Sigma, Lean Manufacturing, Process Mapping, SPC, RCA, DOE, Gauge R&R, technical data interpretation, hardware/software experience
Preferred skills
Single use disposable kits experience
Technologies
Microsoft Word, Excel, PowerPoint, Project, Minitab, Visio
Responsibilities
Coordinate collaboration programs with third parties for NPIs and manufacturing transfers; Create and review change control strategies and technical design documents; Support development and improvement of manufacturing processes and Quality Systems; Write and approve site documentation for QMS compliance; Develop process improvement plans using Quality tools; Identify and report EHS, Quality, or Compliance concerns.
Seniority
Mid-level, hands-on IC
