Senior Quality Engineer, New Product Introduction (24 Months fixed term)
Core
Lead quality controls, process validation, and supplier qualification to bring new medical technologies into production and ensure compliance.
Role type
Senior Quality Engineer (New Product Introduction)
Builds
Medical device manufacturing processes and validated production systems
Domain
Medical devices / Manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process validation, risk assessment, supplier quality management, statistical analysis (DOE, hypothesis testing), PPAP, regulatory compliance (FDA/ISO), measurement system analysis
Preferred skills
Sterilization validation, sterile packaging processes, manufacturing transfer activities
Technologies
PPAP, Gage R&R, DOE, FDA QSR, ISO standards
Responsibilities
Lead risk assessments and define quality controls; Develop and validate inspection methods; Lead supplier component qualification; Execute process validation strategies; Support product and manufacturing transfers; Monitor post-launch product performance and lead investigations; Train quality personnel and support audits
Seniority
Senior, hands-on IC
