Document Control Specialist (Temp) Zeltiq Aesthetics, Inc.
THIS JOB HAS EXPIRED Description
This is a 6 (six) months temp position. The primary responsibility of this position is developing and maintaining document control systems that include the change control process, employee training management, maintenance of electronic and hard copy files of all Quality System Documents.
Essential Duties and Responsibilities include the following (other duties may be assigned.):
? Create, track and maintain records and databases for Engineering Change Orders.
? Responsible for updating Company?s ERP System with relevant data for BOM Control and related documentation.
? Ensure that quality records are consistent with Good Documentation Practices.
? Coordinate with outside services as needed in obtaining new or revised standards. Co-ordinate the internal review and posting of these documents.
? Drive, track and maintain employee Quality training.
? Internal auditing of documentation practices and controls.
? High School diploma or equivalent. College degree is preferred.
? A minimum of 5 years of quality systems experience in FDA regulated medical device manufacturing environment(s).
? Experience with electronic PLM/document change order system desirable.
? Ability to focus on and achieve scheduled milestones, including contingency planning.
? Audit experience preferred.
? Knowledge of QSR, 13485:2003, and 14971:2007.
? Problem solver.
? Competent using office software including MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.
? Ability to read technical literature and documents and extract important concepts.
? Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
? Ability to use MS Excel to perform calculations and interpret results/data.
? Good oral and written communication skills.
? Ability to write reports, specifications, and business correspondence.
? Ability to effectively present information and respond to questions from groups of supervisor, engineers and managers.
? Responsible for performing all duties in compliance with FDA?s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ZELTIQ complies.
||Pleasanton, CA |
THIS JOB HAS EXPIRED