Microbiology Quality Engineer
hace 2 meses
**About Boston Scientific Corporation**:
Boston Scientific Corporation is a global medical technology leader with a passion for innovation that drives us to solve some of the most important healthcare industry challenges. We believe that our diversity and inclusion are key drivers of our success and that by embracing our unique backgrounds and perspectives, we create a better place for our employees to work and reflect the patients, customers, and communities we serve.
**Job Summary**:
We are seeking a highly experienced Microbiology Quality Engineer to join our cross-functional team at BSC Cartago West. This is a unique opportunity to be part of the establishment, development, and maintenance of procedures related to Microbiology and Sterilization to meet regulatory requirements, corporate policies, internal policies, and business needs to support the successful launch of transfer products.
**Responsibilities**:
- Support the Controlled Environment Rooms and critical systems qualification processes.
- Establish and maintain the monitoring program of controlled environments in the new Cartago West site.
- Serve as senior matter expert on sterilization and microbiology, assuring the product meets documented requirements and that processes are controlled.
- Establish and maintain the finished goods microbiological testing program.
- Lead the establishment of Microbiology Lab procedures in alignment with 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 ́s new equipment.
- Review test results and reports.
- May supervise the Microbiology Lab ́s technical and professional personnel.
- Create budgets for the Microbiology Lab.
- Coordinate the purchase of the equipment needed for the laboratory ́s operation.
- Participate as internal auditor in ISO 13485 and GRS/GMPS.
**Requirements**:
- Licenciature degree in Biotechnology, Microbiology, Chemical, or Related Field.
- English Level desired: B2:(80-89%).
- Desired knowledge: Sterilization of medical devices, Microbiology Control for Cleanrooms, Microbiology testing validation and Controlled Environment Qualification.
- At least 5 years of experience in similar position.
**What We Offer**:
Boston Scientific Corporation is an equal opportunity and affirmative action employer, committed to creating a diverse and inclusive workplace. We offer a collaborative culture driven by a passion for innovation, a deep caring for human life, and a commitment to making a difference in people's lives around the world.
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