Supv, Documentation

Job Category: Quality Assurance/Safety Company: Baxter Healthcare Reference Code: 30527BR-1 Supv, Documentation Baxter International Inc., assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives. Manage the day-to-day documentation activities to include the creation, revision, issuance, review, and storage of controlled quality records. Ensure that SOPs and related documentation are maintained in accordance with regulatory requirements and in-house specifications. Interface with development and technical support groups in the management of information. Review, approve, and manage documents for accuracy and completeness. Initiate/revise documents as needed. Support and participate during internal and external inspections as needed. Track and trend Document Control quality indicators. Ensure implementation of divisional procedures, corrective and preventive action items, and audit finding corrective action plans. Participate in continuous improvement initiatives such as QLP, Lean, and 6-Sigma. Participate in annual strategic planning process. Develop, recruit, train, coach, discipline, and assess performance of staff. QUALIFICATIONS: Good working knowledge of Windows based applications. Solid communication skills – both written and oral. Frequent interaction with all levels of employees. Ability to demonstrate strong organizational skills. Work effectively independently and in team environment. Ability to resolve conflict in a positive and proactive manner. Extensive working knowledge of applicable quality and regulatory standards and regulations (CFR Part 820, Part 211, ISO 13485). General working knowledge in Lean and other continuous improvement tools. Working knowledge of related business systems (e.g., Metaphase, Trackwise, ISOTrain) is preferred. Bachelor degree preferred. 3 plus years of related experience in quality management. Prior supervisory experience preferred. As a global leader dedicated to building the best team in health care, Baxter offers competitive compensation and full benefits. To view other opportunities at Baxter, please visit our Careers@Baxter site. EOE M/F/D/V.