Supervisor- Document Control- Abaxis Union City

Point of Care Blood Laboratory Systems, Anytime, Anywhere. Abaxis is a pioneer in the development and commercialization of leading-edge innovative technology, tools and services that support best medical practices, enabling practitioners to respond to the health needs of their patients, while operating economical and profitable practices, at the point of care. Abaxis Inc, a manufacturer of blood point-of-care diagnostic systems based out of Union City, is seeking qualified candidates for the following role: Supervisor, Document Control DESCRIPTION: Oversee the development, coordination and maintenance of the company’s Controlled Document System. Establish procedures and policies needed to meet the demands of document control in a medical device company. This position is responsible for ensuring that Abaxis’ Quality System is established and maintained in compliance with applicable regulations; developing and managing the company’s Document Control function (including electronic records); defining and overseeing the company’s Training program; and participating effectively as the functional escort during third party audits. • Hire, train and supervise document control staff. • Develop and establish the company’s documentation structure, ensuring appropriate linkages. Create and maintain the “Where Used” database. • Facilitate approval of DCOs. • Maintain Device Master Records (DMRs), Device History records (DHRs), procedures, technical literature, user instructions and manuals. • Write/facilitate the development of functional Quality System documents to ensure compliance with applicable regulations, while incorporating industry best practices. • Establish and maintain the company’s electronic Document Control system, including Labeling and Artwork Approval. • Ensure that all quality records are organized and centrally maintained in Document Control such that they are readily retrievable. • Maintain all Document Control computers with attention to security and disaster recovery controls. • Assist with the creation and modification of Engineering Drawings. • Manage/coordinate translations for all company product related literature • Organize and maintain product Design History Files (DHFs). • Control and manage Laboratory Notebook issuance. • Ensure all Documents of External Origin are maintained in current status and that affected departments are notified of changes in a timely manner. • Review and release Document Change orders (DCOs) for Standard Operating Procedures (SOPs), manufacturing instructions, and other Quality System documents. • Effectively support and participate in internal, customer and third party audits. • Develop and conduct training regarding controlled document format, content and usage. • Deliver company-wide training on Good Documentation Practices (GDPs) and oversee effective implementation. • Manage the Training Program for the company to ensure that training requirements for employees have been adequately assessed and are in current status. • Maintain current and in-depth and current knowledge of FDA and applicable international policies and regulations that may affect the company's products and customers. • Participate in Quality System improvement initiatives, as assigned. REQUIREMENTS: • Excellent oral and written communication skills. • Proficient in word processing, with superior attention to detail. • Ability to expediently create document formats with highly professional output. • Demonstrate appropriate sense of urgency with regards to responsiveness with addressing any high risk compliance issues. • Demonstrated organizational, prioritization, and time management skills. • Proficiency in desktop software applications such as Microsoft Word, Power Point, Visio and Excel. • Solid collaboration and team skills. • Strong ability to multi-task and work independently. • BA or BS in any discipline. • Lead Auditor certification preferred. • Ten plus years experience in a senior document control role in IVD/medical device companies. Please apply on-line at: www.abaxis.com Follow us on Twitter: http://www.twitter.com/piccoloxpress ABAXIS IS AN EQUAL OPPORTUNITY EMPLOYER