Quality Engineer II

Job Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Performs Quality and technical review of Nonconformance investigations (NCs) and CAPAs within defined timeframes. Ensures investigations and root cause analysis are accurate and complete. Maintain an accurate log of non-conformances and CAPAs activities. Tracks, follows-up and assists in the timely closure of NCs/CAPAs. Provides hands-on guidance and training to all personnel performing activities within the Quality system. Ensure documentation is complete before closure. Assist Quality Systems team as needed to investigate Nonconformances and ensure proper implementation of CAPAs. Prepare monthly and quarterly metrics to present at Quality Review meetings. Maintains a thorough understanding of the following regulations and guidelines: U.S. Food and Drug Administration (FDA) regulations, ISO 9001, ISO 13485, Medical Device Directive (MOD), the Canadian Medical Device Regulations (CMDR), Corporation's policies and procedures, and other applicable regulatory agency requirements. Interact and coordinate activities with other departments, external vendors and customers. Perform other Quality Systems related duties as required. Skills: Demonstrates knowledge of investigations, root cause analysis, quality systems, the CAPA system and technical writing. Demonstrates excellent organizational and communication skills. Proficient with the MS Office Suite, and statistical software. Must be able to work independent with minimal supervision. Education/Experience: Bachelor’s degree in science (Biology, Chemistry) or Engineering (Biomedical, Mechanical, Chemical, or Electrical) preferred. 3 to 5+ years of experience in a Quality Assurance role for medical device or pharmaceutical manufacturing. #J-18808-Ljbffr