Quality Engineer II

Quality Assurance Specialist

Pay Range $47.1hr - $52.1hr

Requirement/Must Have:

• 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.
• 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.

Responsibilities:

• 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 (MDD), the Canadian Medical Device Regulations (CMDR), the 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.