at Astrix Technology in Abbott Park, Illinois, United States
Quality Assurance Specialist – Medical Device
Competitive Pay – Desirable Hours – Great Organization for Career Growth!
The Specialist will complete data and document audits to ensure application integrity, accuracy, consistency and completeness. They will also prepare and issue final audit reports summarizing findings and noting corrective action.
+ Participates in the development & review of all design input, risk management, design verification, design validation and design output/transfer related design change activity.
+ Understands and applies basic Risk Management principles.
+ Understands and applies basic Design Verification/Validation methods & principles.
+ Reviews documentation for accuracy, clarity, consistency, completeness and compliance for projects that vary from low to high complexity.
+ Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate.
+ Bachelor of Science (required) – preferably in engineering, chemistry, biology, or related sciencewith 1-3 years’ of related experiencewith medical devices
+ Experience with design verification and validation, protocol reviews and approvals, Excel (pivot tables), design output and transfer (required)
+ Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines and 21 CFR Part 11
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.