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Senior Microbiologist

Stryker

Mahwah, NJ, 07430, USA

Stryker is an exceptional company with exceptional people who deliver exceptional results. We have differentiated ourselves by advancing meaningful innovations, creating cost-effective solutions for and improving the lives of our global customers and patients. As a winner of the 2007 and 2008 Gallup Great Workplace Award, we have demonstrated that Stryker has one of the most productive and engaged workforces in the world. Our exceptional results fuel ongoing opportunities for Stryker employees to build outstanding careers and to develop and grow both personally and professionally. Our work environment attracts many different kinds of talented and driven people who love to win and serve others. We always put quality first. We hold ourselves accountable to reach or exceed our goals and continually improve everything we do. These attributes are shared by the employees that make up Stryker. They are the things that bring us together and serve as the foundation of all we do. And they are the enablers of both our past and future success.Stryker is one of the world??s leading medical technology companies with the most broadly based range of products in orthopaedics and a significant presence in other medical specialties. The Company's products include implants used in joint replacement, trauma, craniomaxillofacial and spinal surgeries; biologics; surgical, neurologic, ear, nose & throat and interventional pain equipment; endoscopic, surgical navigation, communications and digital imaging systems; as well as patient handling and emergency medical equipment. For more information about Stryker, please visit the company web site at:
http:
//www.stryker.com. JOB DESCRIPTION:
Identifies, isolates and studies microorganisms and their byproducts as it relates to the sterilization of medical devices. Maximize the biocompatibility of products using industry guidelines and advanced testing technologies. Will work closely with operations and research groups to develop new products and will lead continuous quality improvement initiatives. Responsible for coordinating and completing projects with minimal supervision.Essential Duties & Responsibilities:
???Apply cGLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines to the bioburden, cytotoxicity, bacterial endotoxin, and biocompatibility analysis of orthopaedic implants and surgical instruments.???Actively lead and support new product development activities.???Lead and participate in the development and improvement of the manufacturing processes for existing and new products.???Lead in the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ).???Be the subject matter expert and point of contact for suppliers for new process development, quality issues and process improvements for assigned projects.???Support product transfers to other plants/facilities. ???Review/approve nonconforming material and system documentation. ???Review/approve product and process change control documentation and specifications.???Participate in or lead continuous (breakthrough) improvement activity and process re-engineering projects in support of Stryker Orthopaedics Business Process Excellence initiative.???Act as mentor to others.Qualifications:
???Must have 7+ years of applied device or pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience.???Functionally knowledgeable about a variety of microbiological concepts, practices, and procedures.???Must be intimately knowledgeable of at least one of the following sterilization techniques:
gamma irradiation, ethylene oxide, hydrogen peroxide gas plasma, moist heat, or dry heat, and possess a working familiarity with the others. ???Must be capable of maximizing the biocompat

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