Microbiologist in Cestas, France

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Within the Quality Sciences team, the Microbiologist will be primarily responsible for the sterility compliance of Strykers products in accordance with relevant regulatory requirements and standards for medical devices. The Microbiologist will ensure sustained levels of compliance through testing, monitoring and validation of cleaning and sterilisation processes and associated utilities.

Your Main Responsibilities :

Will work within the Quality Sciences team, under general supervision, 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.

• Monitoring of utilities including all grades of water, and where necessary, compressed air.

• Co-ordination of samples for microbiological and residual testing

• Ordering consumables (media etc) and general stock for day-to-day running of laboratory.

• Applying cGLP to all laboratory activities including stock control.

• Performing sampling and validations / (re-)qualifications as required.

• Interpreting sampling and monitoring data, applies statistical and analysis techniques, to determine control and trending.

• Input to NC and CAPA generation and resolution within the Microbiology group and across related business units. Competency into correction of NCs.

• Performs sterility release review.

• Proficient in local procedures and practices.

Your Profile :

Knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).

• Experience in a Quality/Regulatory Affairs environment desirable.

• Ability to build knowledge and understanding of US and International Medical Device Regulations and standards in area of expertise (Microbiology)

• Must possess strong communication skills as well as have the ability to manage multiple tasks simultaneously.

• Strong interpersonal skills.

• Demonstrated ability to work independently.

• Ability to be proficient in statistal techniques, data review and analysis.

• High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.