at ICONMA, LLC in North Chicago, Illinois, United States
Job Description
Job Description
Performs data and document audits to ensure application integrity, accuracy, consistency and completeness. Prepares and issues final audit reports summarizing findings and noting corrective action. WHAT YOULL DO The Specialist Quality Assurance within Client Diagnotiscs Division will analyze quality standards for components, materials or services. Apply measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met. Design/Change Control – Responsibilities include participating in the development & review of all design input, risk management, design verification, design validation and design output/transfer related design change activity. Risk Management Understands and applies basic Risk Management principles. Participates in the development and/or modification of Risk Management Files, FMEAs, etc. Design Verification/Validation Understands and applies basic Design Verification/Validation methods & principles. Participates in the development, modification and design review of Protocols, Data Summaries & Records. Documentation – Reviews documentation for accuracy, clarity, consistency, completeness and compliance for projects that vary from low to high complexity. Plans and performs assignments with a wide degree of difficulty. Quality System Compliance -Maintains awareness of standards that regulate our industry. Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate. Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management. Quality Engineering Participates on project teams and technical review boards. Coordinates quality decisions between different quality and engineering groups. Effectively navigates & facilitates project teams with respect to our processes and procedures ensuring the delivery of safe and effective products. Apply quality principles, analyzes quality records, prepares reports and recommends improvements. Conduct inspection, verification and validation of components or materials used in development processes. Document quality issues and performance measures for management review. EDUCATION AND EXPERIENCE YOULL BRING Required Bachelors Degree Required Preferred Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines and 21 CFR Part 11 As an equal opportunity employer, ICONMA prides itself on creating an employment environment that supports and encourages the abilities of all persons regardless of race, color, gender, age, sexual orientation, citizenship, or disability.