Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World's Best Workplaces, apply now !
Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team
23 month contract
Who we want:
- Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
- Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
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What you will do:
The Senior Microbiologist will be primarily responsible for the sterility compliance of Strykers product in accordance with relevant regulatory requirements and standards for medical devices. The microbiologist will oversee and ensure sustained levels of sterility compliance through testing, monitoring and validation of cleaning and sterilisation processes and associated utilities.
Position Requirements
Will work within the microbiology 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 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.
- 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 for validations and re-qualifications as required.Review of validation files for compliance.
- Strong interactions, maintainance 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, intepretaing data and trends.
- Performs sterilisation 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 you will need:
- Level 8 Degree
- 2 years Microbiology related experience.
About Stryker
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 130 million patients annually. More information is available at stryker.com.