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about the companyLifeCell Corporation (Nasdaq:LIFC) is a bioengineering company engaged in the development of and commercialization of tissue regeneration products. When an organ or tissue donor gives to improve the quality of life for those in need, we begin the process of helping others. It takes committed, caring people to help in the daily research - people like you. Among Fortune’s 100 Fastest Growing Companies in 2005 and 2006, LifeCell is a pioneer in products related to regenerative medicine. With the stock price up nearly 400% in the last four years, LifeCell continues to attract top talent from best-in-class companies We have the following opportunity available: position descriptionQuality Compliance Auditor
LifeCell develops and markets tissue repair products for use in reconstructive, urogynecologic and orthopedic surgical procedures. LifeCell's current marketed products include: Strattice™ Reconstructive Tissue Matrix and AlloDerm® Regenerative Tissue Matrix, for plastic, reconstructive, general surgical, burn and periodontal procedures; Cymetra® Regenerative Tissue Matrix, a particulate form of AlloDerm® Tissue Matrix suitable for injection; Repliform® Regenerative Tissue Matrix, for urogynecologic surgical procedures; GraftJacket®, for orthopedic surgical procedures; and AlloCraft™DBM, for bone grafting procedures. Lifecell currently has an opening for a Quality Compliance Auditor located in The Quality Compliance Auditor will work to foster compliance to the LifeCell Quality Management System by conducting supplier and internal audits. Provide support, guidance, and follow-up to ensure corrective & preventative action and closure of audits. This position will perform tracking & trending of supplier metrics for management review & identify improvement plans. PRINCIPAL RESPONSIBILITIES: 1. Maintain a thorough understanding of applicable regulations and guidelines: FDA Current Good Tissue Practices (21 CFR 1270/1271), AATB Standards for Tissue Banking, all applicable ISO standards, Quality System Regulation (21 CFR 820), LifeCell corporation policies and procedures, and other applicable regulations / standards. 2. Audit suppliers with respect to all relevant guidance, rules, regulations and requirements. 3. Conduct internal audits with respect to all relevant guidance, rules, regulations and requirements. Ensure consistency of systems/practices across product lines and their conformance to other industry practices. 4. Conduct tracking & trending of supplier performance for management review & identify corrective & preventative actions. 5. Development of internal operating procedures, ensuring the proper specifications for equipment and processes through validations and/or qualification. 6. Support external audits of LifeCell ensuring the identification of corrective action and closure within established timeframes. QUALIFICATIONS: MINIMUM EDUCATION: BA or BS Degree – technical (physical or life sciences or engineering) or equivalent experience. Professional certification by ASQ or similar body is required. CTBS certification is preferred. MINIMUM SKILLS AND EXPERIENCE: 3-5 years’ technical/engineering experience. Specific experience in medical device quality assurance methods and practices is preferred. WORKING ENVIRONMENT: Varied schedule with some potential weekend and evening hours. Approximately 75% travel COMMUNICATION REQUIREMENTS: Excellent oral and written communication skills, with the ability to interface effectively and professionally at all levels. |
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