Job Openings in Sacramento County and Beyond
Sr. Medical Device Quality Engineer - Direct Hire
Sacramento, CA | Direct Hire Position
Responsibilities: Provides Quality Engineering support within new product development, operational, or system/services support. Provides leadership and technical support for the Quality Assurance, Quality Control, and Engineering functions. Develops, establishes and maintains Quality Engineering methodologies, systems, and practices which meet company, customer, and regulatory requirements. Serves as a Quality Representative to improve awareness, visibility, and communication on quality initiatives. Supports shelf life and biocompatibility testing and creates associated test procedures and reports. Effectively assesses risk of design and process controls to assure high quality. Creates and updates product risk analyses and risk management files. Regularly monitors, investigates and reviews nonconformance activities and generates CAPAs/SCARs based on trends/issues identified from operations, MRB and drive them to closure. Performs thorough root cause analysis investigations for nonconforming product, field complaints, and supplier issues; and implement effective corrections. Facilitates Risk Management activities throughout the productlifecycle. Ensures suppliers deliver quality parts, materials, and services by effectively qualifying and monitoring supplier performance.
Requirements: B.A or M.A. Degree in Mechanical or Plastics Engineering required. 5+ years progressively responsible experience with Quality/Inspection functions in a medical device manufacturing environment. Failure investigations in a manufacturing environment. High performing leadershipskills, prioritization, communication (verbal and writing). Process Excellence (Six Sigma) and/or ASQ certifications preferred.