9-12 month contract position for a QA Engineer for a medical device distribution center.
Primary responsibilities will include: Supporting Quality management – ensuring that corrective and preventive actions are issued as required, properly investigated, documented, effective, and completed on time, and that internal audits are properly performed, documented, and completed in accordance with the annual audit procedure/schedule.
Supporting Supplier management, which includes maintaining supplier corrective actions, supplier audits, supplier certification, non-conforming material review and supporting incoming material inspection.
Reviews and approves product/process qualification/validation and other change control related documentation.
Performs inspection of incoming materials; ensure inspection records are maintained.
Investigates product issues by conducting failure investigations, complaint trending, and Product Inquiries.
Communicates and interacts with other functions within the company, provides data and investigation support as needed.
Requirements
Minimum of AAS degree, BS degree preferred.
Experience in QA, QA engineering or related.
Experience in FDA regulated industry or ISO certified organization is required.
Experience working in a distribution center, a logistics function, or manufacturing environment strongly preferred.
