Job Openings in Sacramento County and Beyond

Sr. Medical Device Quality Engineer - Direct Hire

Sacramento, CA | Direct Hire Position

Post Date: 11/07/2017 Job ID: 38760.1 Industry: Technical
A cutting edge medical device and technology company in the Greater Sacramento Area is seeking a seasoned Quality Engineer to maintain and administer quality assurance procedures and activities. The ideal candidate will have experience with mechanical or plastics engineering for medical devices. This is a full time, direct hire opportunity with a company that offers great growth potential.Apply today!

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 product lifecycle. 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 amedical device manufacturing environment. Failure investigations in a manufacturing environment. High performing leadership skills, prioritization, communication (verbal and writing). Process Excellence (Six Sigma) and/or ASQ certifications preferred.

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