Stryker - Fremont, CA

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Stryker offers results-driven people a place where they can make a difference. It is our privilege to create medical technology that exceeds our customers’ expectations and improves peoples’ lives around the world. We give you the opportunity to develop your career based on your strengths and potential, including the possibility to move geographically, functionally, laterally and vertically. Stryker is a career destination for engaged, passionate and talented people who seek the innovation, growth and opportunity that only we offer.

Job Summary:
Manage activities of the Microbiology Lab and environmental testing ensuring compliance to GQO and Divisional requirements. Provides guidance to R&D and Operations on requirements for new product and environmental control. Supports continuous quality improvement initiatives.

Essential Duties & Responsibilities:
  • Manage Microbiology, Sterilization, and Biocompatibility projects.
  • Manages the Microbiology laboratory activities.
  • Provide guidance on Operations Activities to ensure continued compliance with internal SNV and GQO requirements.
  • Coordinate cross functionally and perform microbiology testing including environmental monitoring, LAL and bioburden evaluation of medical devices and water system.
  • Coordinates testing with external test facilities, reviews and approves protocols and reports.
  • Provides guidance and supports new product development activities for Sterilization, Microbiology and Biocompatibility.
  • Responsible for conducting Biocompatibility, Microbiology and
Sterilization evaluations.
  • Lead and support the execution, development and/or improvement of microbiology and sterilization processes.
  • Responsible for the review, generation, and execution of the sterilization process and equipment validation/qualifications.
  • Support product and company integration projects.
  • Ensure compliance to new standards and technology for Sterilization, Microbiology and Biocompatibility.
  • Other duties as assigned
Qualifications/Education/Work Experience Required:
  • BS in Biology, Microbiology, or a closely related life science
  • Minimum of 2 years of device or pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience or experience in Academic Research.
  • Demonstrated knowledge in sterilization, environmental and microbiological techniques. Demonstrated experience in microbial identification and environmental isolates.
  • Knowledge of biocompatibility and EtO and GAMMA sterilization.
  • Demonstrated knowledge in microbiological, sterilization and biocompatibility concepts, practices, and procedures.
  • Demonstrated creativity, good judgment and technical expertise.
  • Works cross-functionally with Product Development, Marketing and Operations in new product development, product testing and environmental support.
  • Demonstrated organizational and interpersonal communication skills
  • Must be a team player, and an advocate for product excellence and quality.
  • Must be results oriented, a quick learner, and able to respond to the urgent needs of the team ensuring all deadlines are met.

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Stryker is one of the world’s leading medical technology companies and together with our customers, we are driven to make healthcare...