Quality Assurance Doc. Control Engineering Assistant
Kelly Engineering Resources (Boston, Massachusetts)

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Kelly Engineering Resources® specializes in providing companies around the world with qualified engineers, designers, drafters and technicians. We are part of Kelly Services®, a US-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world. We currently are recruiting for an Engineering Assistant for client in Aurora, Ohio. Following are the responsibilities and required skills for the incumbent. Position is a lucrative opportunity to develop new skills or improve skills, and strengthen resume. For immediate consideration apply today!! ESSENTIAL DUTIES & RESPONSIBILITIES: +Support Device Master file maintenance. +Review newly released Device Master records and changes to existing records to ensure proper revision control. +Generate and maintain 'controlled copies' of multiple sets of Device Master records. +Issue Device History Record shop packets to production. +Maintain and issue serialized labels. +Create special labels as needed. +Maintain logs of all issued DHRs and labels. +Find/replace missing Device Master Record documents. +Maintain QA controlled quality manual and procedures. +Supervise final Device History Record review and preparation for storage. +Ensure proper record keeping for stored Quality Records. +Maintain Design History Files. +Support Engineering Document Change Control system. +Serve as back-up for Engineering Change Control Specialist. +Support efforts to evolve into paperless system. +Provide general clerical and administrative support to QA as required. +Will supervise Device History Record clerk in review and preparation of documents for storage. QUALIFICATIONS +Associates degree or equivalent. +1 ' 3 years experience in fast-paced engineering/manufacturing department. +Able to maintain control of complex documentation systems under extreme pressure. +Excellent communication and interpersonal skills. +Experienced in creating procedures, work instructions and forms. +Proficient in all Microsoft Office applications plus be able to learn CorelDraw. +Experienced in paperless document control systems. DESIRED +Experienced in paperless document control systems. +Experience with Medical Device compliance requirements for document control. +Experience creating FDA filings (510K, PMA, etc). ADDITIONAL INFORMATION +Must take ownership for quality and accuracy of Device Master Records and shop packets issued to production. +Must be very well organized and be able to establish and maintain paper and electronic filing systems for a variety of document types. +Must be able to understand and comply with FDA and EHS requirements. +Support New Product Introduction and Change Control activities in an ISO and FDA compliant organization. +Cross functional role, requiring regular communication with engineering, production and Quality in support of New Product Introductions and ongoing maintenance of files and documents.