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 independently 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.