Quality Engineer
Core
Ensuring compliance with Quality System Regulations for manufacturing processes and methods at the Aibonito facility, providing technical and statistical support for process control.
Role type
Quality Engineer I (IC)
Builds
Hospital products compliant with internal and external regulations
Domain
Healthcare manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Statistical analysis, Root cause investigation, Process validation, GMP/GDP compliance, Defect analysis (DPM), Quality sampling plans, Protocol development, Regulatory risk assessment
Preferred skills
Engineering management practices, Technical reporting, Multidisciplinary team coordination, Software validation knowledge
Technologies
Trackwise, TcU, Microsoft Office, Outlook
Responsibilities
Conduct Non-conformance Investigations and approve as quality representative; Lead assigned programs (e.g., Sterilization, Parametric Release) from the quality standpoint; Evaluate customer complaints; Prepare Quality Data Review on a monthly and quarterly basis; Participate in internal and external audits; Support the design and development enhancement of product processes and technologies modifications.
Seniority
Junior, hands-on IC
