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Sr Staff Microbiologist Role, Macroom, Cork
Hybrid - 3-4 days onsite
Your key responsibilities:
* Define local quality strategy to deliver safe, high-quality clean and sterile products while maintaining regulatory compliance
* Oversight of Micro & Sterility key processes cleaning, cleanroom, sterilization and product testing
* Coach, mentor, and drive awareness to other functions in area of Micro & Sterility
* Subject matter expert to internal & external regulatory requirements (Corporate, FDA, ISO) and local procedure owner
* Interpreting sampling and monitoring data, applies statistical and analysis techniques, to determine control and trending.
* Review and approval Cleaning / Cleanroom Equipment/ Process qualification/ validation / monitorings/ test reports
* Timely communication, escalation, resolution of product issues causing supply chain disruptions
* collaboration for cleaning/ sterilization/ environmental across sites in a global team across T&E Franchise
* Continually identifies opportunity to drive efficiencies and margin improvements
* Support compliance to Micro & Sterility standards in product transfers and new product introductions
What are we looking for:
* Bachelor’s degree/ Master of Microbiology or equivalent
and
* Minimum of 6 years relevant experience
* 2 years Microbiology related experience.
* Experience in interacting with regulatory agencies (MDSAP, FDA, MoH, TUV, etc.) required.
* Thorough knowledge and understanding of US and International Medical Device Regulations and standards in area of expertise (Microbiology)
* Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
* Strong interpersonal skills.
* Strong written and oral communication and negotiations skills.
* Strong in critical thinking and "outside the box" thinking.
* Highly developed problem-solving skills.
* Strong analytical skills.
* Demonstrated ability to successfully manage and complete projects in a matrix organization.
* Demonstrated ability to work independently.
* Experience in working in a compliance risk situation.
* High proficiency in statistical techniques, data review and analysis.
* High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel, and PowerPoint packages.
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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.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Research, Analyst, and Information Technology
* Industries
Appliances, Electrical, and Electronics Manufacturing, Industrial Machinery Manufacturing, and Medical Equipment Manufacturing
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