Quality Engineer I
Core
Ensures product quality assurance, process improvement, and compliance with FDA/ISO regulations for medical diagnostics instruments.
Role type
Quality Engineer I (Manufacturing/Operations)
Builds
Medical diagnostics instruments and related quality systems
Domain
Healthcare / Medical Diagnostics
Required skills
root cause analysis, statistical analysis, technical writing, process improvement methodologies, quality system compliance
Preferred skills
Minitab, JMP, supplier quality programs, validation activities
Responsibilities
Review qualifications, validations, and technical studies for compliance; Serve as Quality representative for qualification and validation review; Support Material Review Board (MRB) process and manage nonconforming materials; Review and participate in disposition of quality incidents; Support supplier quality management activities; Develop test plans, inspection plans, and quality-related procedures; Support internal and external audit programs; Maintain effectiveness of the Quality Management System.
Seniority
Entry-level to Mid-level, hands-on IC
