Supervisor Laboratory Services

It is MEDRAD's mission to be a worldwide market leader of medical devices and services that enable or enhance diagnostic and therapeutic imaging procedures. MEDRAD performance is a result of an unrelenting commitment to improving healthcare, to upholding standards of excellence, and to responsible activities for the benefit of our customers, shareholders, employees, and communities. These values are expressed through our culture and philosophy, as well as our ethical and corporate responsibility policies. MEDRAD has over 1,700 global employees, 1,200 of whom are in the Pittsburgh area. MEDRAD's European headquarters office is located in Maastricht, The Netherlands. Our Asian headquarters office is in Osaka, Japan with additional international offices located in France, Germany, Italy, China, UK, Brazil, Norway, Belgium, Sweden, Denmark, Singapore, Egypt, Mexico, Cyprus and Australia.

Position Description:

The purpose of this position is to supervise a laboratory that performs microbiological, toxicological, and chemical testing in support of Medrad Sterile Disposables manufacturing operations. Responsibilities of the position include:1. Responsibility for providing Microbiological laboratory services for sterilization operation support, including sterilization validation support and routine microbiological testing in support of sterile product release.2. Coordinating special testing (internal and external) to support sterilization validation activities for new processes, including EO residuals and dissipation studies.3. Responsibility for providing endotoxin testing in support of product release.4. Supporting routine testing and monitoring of critical systems, including environmental bioburden and particulate level monitoring for a cleanroom manufacturing environment, product bioburden monitoring, and water system monitoring and control measures.5. Maintaining laboratory testing records associated with all laboratory functions and other records required for information processing and release purposes. Performing release of sterile product and assuring compliance to established testing requirements.6. Supervision of the QA Laboratory Services technical staff and overseeing operational aspects of the lab (including budget and lab inventory).7. Coordinating all Laboratory activities in support of strategic improvement initiatives for the Sterile Disposables manufacturing plant and Operations Quality.1. Bachelors Degree in Biology, Microbiology, or related scientific discipline is required. Masters degree is preferred.2. 5 years working experience in a laboratory and medical device industry is required.3. 5 years working knowledge of industrial sterilization and aseptic techniques is required.4. 3 years working knowledge of endotoxin testing is required.5. Proven understanding of basic Microbiology and/or experimental design is required.6. Experience with FDA Regulations and/or ISO QS Standards is preferred.7. Working knowledge of biocompatibility and/or quality principles is preferred.8. Working knowledge of Microsoft Office Applications.9. Strong competency in Customer Focus, Driving for Results, Integrity and Trust, Ethics and Values and Compassion. 10. Proven ability to demonstrate at minimum MEDRAD’s Supervisor competencies: Decision Quality, Developing Direct Repots, Motivating Others, Managerial Courage and Business Acumen.

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