Job Openings in Sacramento County and Beyond
Quality Engineer - Direct Hire
Sacramento, CA | Direct Hire Position
Responsibilities: Supports the manufacturing of Disposable Devices to achieve quality and business objectives through sustainable and continuous improvement activities. Ensures compliance and other applicable regulatory and industry standards. Effectively assesses risk of design changes and process controls to assure high quality. Analyzes quality system data (field complaints, nonconforming product, etc.) to identify adverse trends and opportunities for continuous improvement. Creates standards, metrics and procedures. Manages workflow of specification review process. Perform other duties as assigned.
Requirements: Minimum 5 years related experience in Mechanical or Plastics Engineering for medical devices. Degree in engineering or related technical discipline. Experience in Root Cause Analysis and Corrective Action/Preventative Action (CAPA). Product Risk Management throughout the product lifecycle. Design Controls in accordance with 21 CFR 820. Quality ManagementSystems (ISO 13485, 21 CFR 820). Failure investigations in a manufacturing environment. Blue print reading and interpretation including Geometric Dimensioning and Tolerance (GD&T) is preferred. High performing leadership skills and communication. Self-starter, motivated, able to prioritize tasks and meet deadlines. Excels in use of Microsoft Office suite and statistical analysis software such as Minitab. Process Excellence (Six Sigma) and/or ASQcertifications is preferred.