About the role: 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 sites 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 Labs new equipment.
:Oversee the validation of the Microbiology Labs new equipment.
:Review test results and reports.
:Supervise the Microbiology Labs technical and professional personnel.
:Create budgets for the Microbiology Lab.
:Coordinate the purchase of the equipment needed for the laboratorys 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 we are looking for:
:Licenciature inMicrobiology
:5+ years of experience
:English level: 70 : 79
:Desirable experience in ISO 13485 andQSR/GMPs.
:Internal auditor experience is a plus
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.