At Terumo Cardiovascular, we develop, manufacture and distribute medical devices for cardiac and vascular surgery with an emphasis on cardiopulmonary bypass, intra-operative monitoring and vascular grafting. This includes a full-line of perfusion products, endoscopic vessel harvesting products and surgical stabilization products.
Our mission is to work as a team to save one more life, today and every day. We do this by providing lifesaving technology to cardiac surgery teams around the world.Job Summary
This position is responsible for directing the Microbiology/Chemistry Laboratory and Sterilization programs, serving as technical advisor to corporation's Quality Management, Regulatory Management, and site management.
1. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
2. Responsible for the implementation of domestic and global regulations in the applicable area of Laboratory and Sterilization issues.
3. Develop and direct the Company's corporate sterility assurance program and contamination control program which includes; (a.) Radiation Sterilization Validation for Establishing & Maintaining Minimum Dose Requirements and provide guidance in the area of Dosimetic Aspects; (b) Ethylene Oxide sterilization cycle development and validation, annual re-qualification, bio-burden control process, etc.; (c) Provide guidance in the Material Safety evaluation program concerning material Biocompatibility issues; (d) Contamination control - environmental monitoring and control, ( e ) knowledge and management of additional sterilization methods as applicable, Associate education, etc.
4. Serve as technical advisor in the areas of product sterility, material safety, Endotoxin/pyrogens product contamination, bioburden, sterilization validation, and other microbiological technical related issues.
5. Establish and maintain technical supplier relationships with contract test laboratories, contract sterilizers, Biological Indicator suppliers, laboratory suppliers, and others.
6. Continually examine the scope of testing services being performed to ensure that the needs of the corporation are met and that testing services comply with regulatory guidelines.
7. Oversee regulatory and compliance issues relating to sterilization issues.
8. Develop test methodologies and equipment/instrumentation validation protocols.
9. May participate in supplier and internal audits.
10. Manage the formulation and implementation of strategic business and quality plans for the Test Management Laboratory and Sterilization Programs.
11. Utilizes the systems and processes in place to attract, develop, engage, train, and retain talented Associates; creating a work environment where Associates can realize their full potential, thus allowing the organization to meet business needs.
12. Perform other duties as assigned.
Requires a four-year college degree in Microbiology or Chemistry and a minimum of eight years of experience in Industrial Microbiology, Industrial Sterilization Technology, Cleanroom Management, or Laboratory Management in medical device or pharmaceutical industry, of which a minimum of five years must be supervisory experience. In addition, experience with Radiation sterilization, Industrial Ethylene Oxide sterilization, Moist Steam sterilization, sterilization Biological Indicators, radiation dosimetry, cleanroom/ controlled environment control and material biocompatibility testing preferred. Intermediate computer software skills, i.e., Microsoft Office.
Terumo Cardiovascular is an equal opportunity employer. We promote recognition and respect for individual and cultural differences, and we work to make our employees feel valued and appreciated, whatever their race, gender, sex, sexual orientation, gender identity and/or expression, and genetic information.
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