Senior Microbiologist in Cestas at Stryker Corporation

Date Posted: 10/4/2019

Job Snapshot

Job Description

On that position you will work within the quality assurance team with responsibility to ensure effective and efficient sterility practices, which includes, but not limited to the following:

• Environmental monitoring of cleanrooms for viable air, viable surface and particulate in line with ISO 14644 standards.
• Monitoring of utilities including all grades of water, and where necessary, compressed air.
• Co-ordination of samples for bioburden and endotoxin testing.
• Performing sampling for validations and re-qualifications as required. Review of validation files for compliance.
• Strong interactions, maintenance and support of sterility suppliers.
• Interact with Supplier quality team with respect to vendor sterility topics.
• Interpreting sampling and monitoring data, applies statistical and analysis techniques, to determine control and trending.
• Leads NC and CAPA generation and resolution within the Microbiology group and across related business units. Strong competency in troubleshooting, correction of NC and root cause analysis.
• Performs sterility release review, interpreting data and trends.
• Performs sterilization validations and re-qualifications in line with relevant BS EN ISO standards.
• Continually identifies opportunity for stabilization of trends, statistical control of processes to allow cost saving.
• Mentors and trains team and cross functional groups as required (induction, GMP etc.)
• Subject matter expert to internal & external regulatory requirements, (including but not limited to European RHQ, Division, Corporate, FDA, ISO, MDD, and individual country regulatory requirements)
• Subject matter expert to local procedures, contribute to the development, maintenance and improvements of the policies and procedures to align to best practices, benchmarking against industry leads and regulatory requirements.
• Coach, mentor and train other functions in area of sterility and monitoring.
• Support of, ensure compliance of new products to sites’ sterility standards. Successful integration of products to validated processes.
• Ensures biocompatible of components, materials and consumables used in the manufacture of Stryker product.

What we search for:

  • Degree in Microbiology or equivalent mandatory.
  • Knowledge of the medical devices field.
  • 3 years minimum of experience in an environment linked to quality / regulatory affairs.
  • 2 years of experience in microbiology

Work From Home: No

Travel Percentage: 10%


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