"Responsible for supporting production line transfers, including creation of Pfmea, leading component qualification activities, and test method development and validation. Ability to integrate into cross functional teams, and ability to find creative solutions to project quality needs, ensuring compliance to quality standards, and product needs. Support launch and initial manufacturing operations and assure documentation and procedures are created, updated and maintained as required by internal Quality Policies and related FDA/GMP guidelines. Conducts failure analysis, assists in the investigation of manufacturing issues during process development and provides data and input on technical issues and projects.
BS or BA in chemical, biochemichal, mechanical, electrical or Industrial Engineering, Biological Sciences, Chemistry or other related field required with minimum 2 years of experience (project management experience preferred).
Must demonstrate a working understanding of the pertinent Quality Systems Regulations (i.e.: Good Manufacturing Practices, ISO, FDA). Proven ability to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance. Capable of using Microsoft programs and ability to learn other systems. Working knowledge of statistical methods as well as statistical application software. Effective verbal and written communication skills. The ability to work in teams and independently with minimal supervision to obtain results as required. Must be self-motivated/directed, organized, detail oriented and have ability to multi-task projects. Professional certification is an advantage (i.e. CQA, CQE, SQE, CQM, Six Sigma, etc.)."