Staff Engineer, QA - Sterilization

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“Ground breaking, life changing careers that reward the power of ideas and innovation” Cordis Corporation, a worldwide leader in circulatory disease management, is seeking a motivated and accountable Staff Quality Engineer to join our quest to defeat vascular disease. During the last 40 years, a deep understanding of the medical marketplace, unrivaled concern for the needs of patients, and high impact technological innovation have made Cordis the leading developer of breakthrough products for interventional medicine, minimally invasive computer-based imaging and electrophysiology. Today, over 7,000 Cordis employees from around the world share a strong commitment to continue our company's groundbreaking work.  As a Johnson & Johnson company, Cordis offers tremendous opportunities and world-class resources. Our decentralized structure provides the feel of a small-company environment with big-company impact. We are focused on developing leaders with a broad base of business and cultural skills, along with a strong commitment to the values expressed in Our Credo. By choosing Cordis Corporation, you are choosing to positively impact the lives of millions of people each year! The Staff Quality Engineer  is responsible for serving as technical expert in sterilization. Working actively with Managers/Supervisors from all disciplines in resolving corrective actions and timely completion of these reports. Actively participates in new sterilization cycle development and product development in relation to sterilization. Reviews sterilization deviations and is involved in the investigation and resolution of the corrective and preventive action ensures compliance procedures and regulatory requirements. Ideal candidate will have extensive leadership skills and experience in the areas of Industrial sterilization methods such as EtO, Gamma, Steam and Dry Heat.  Must be able to write sterilization validation protocols and reports for EtO, Gamma, Steam and Dry heat sterilization. Perform D-value calculations, audit contract sterilizers, write audit reports, write D-value waivers and coordinate D-value testing. Review sterilization run records. Reads and understands technical documentation associated with specific discipline. Must be familiar with aseptic and microbiological techniques and sterilization. Must be knowledgeable in current ISO/AAMI/FDA standards and guidelines. Ability to troubleshoot problems and utilize computer systems to generate reports in Microsoft EXCEL and Word. 

Bachelor's Degree in Microbiology, Biology or other science/engineering degree and 9 or more years of sterilization experience and/or training; or equivalent combination of education and experience. MS in Microbiology, Biology or other science/engineering degree and 7 or more years of sterilization experience. Previous/current experience in the medical device or pharmaceutical industry would be an additional asset. English communication skills, written and oral.