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Purpose and Passion - Comprehensive Benefits - Life:Work Integration - Community - Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purpose-improving lives through your life's work.
About the Role:
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Manage microbiology laboratory tasks. Supervise and coordinate microbiology testing, as per approved procedures and protocols. Validate new or existing equipment in order to assure compliance with regulatory biocompatibility and microbiology standards.
Your Responsibilities Include:
:Serve senior matter expert on biocompatibility, sterilization and microbiology, assuring the product meets documented requirements and that processes are controlled.
:Maintain the monitoring program of controlled environments in the Costa Rica site.
:Maintain the Sterilization Dosage audit program.
:Maintain the finished goods microbiological testing program.
:Maintain the site and acute;s water systems monitoring.
:Make sure all Microbiology Lab procedures meet corporate requirements, as well as international regulations such as QSR/GMPs and ISO 13485.
:Lead tasks related to Microbiology Investigation Systems, such as generation of metrics and monitoring the corrective and preventive actions feeder system.
:Oversee the validation of the Microbiology Lab and acute;s new equipment.
:Review test results and reports.
:Supervise the Microbiology Lab and acute;s technical and professional personnel.
:Create budgets for the Microbiology Lab.
:Coordinate the purchase of the equipment needed for the laboratory and acute;s operation.
:Supervise the decontamination process of returned product as part of the complaint process, in order to guarantee its harmlessness to the analysis.
:Participate as internal auditor in ISO 13485 and GRS/GMPS.
:Act as Quality Engineer for Facilities related matters.
What Were Looking For:
:Licenciature degree in Microbiology.
:English Level required: B2:(80:89).
:Desired knowledge: Desirable experience in ISO 13485, QSR/GMPs, Internal auditor experience is a plus.
:At least 5 years of experience in similar position.
About us
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you're looking to truly make a difference to people both around the world and around the corner, there's no better place to make it happen.
Requisition ID:444029
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