Our client, a medical device company in Cork is currently looking to recruit a Staff Microbiologist for their site.
You will be primarily responsible for the sterility compliance of our clients product in accordance with relevant regulatory requirements and standards for medical devices. This person will oversee and ensure sustained levels of sterility compliance through testing, monitoring and validation of cleaning and sterilisation processes and associated utilities. Part of your duties will be to act as technical lead for microbiology in cross functional groups including product and process issues, root-causing, projects, initiatives and other business critical forums. To be successful in this role you will need to build and foster strong relationships with Stryker's sterility suppliers. Mentoring and training will be key tasks to share knowledge among cross-functional teams and groups.
The Ideal Candidate:
- Bachelor degree Microbiology or equivalent/ related subject required, with 4 years Microbiology related experience OR Masters of Microbiology or equivalent related subject required, with 2 years Microbiology related experience
- PhD desirable
- Minimum of 6 years in Quality/Regulatory Affairs environment.
- Experience in interacting with regulatory agencies (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
- Some travel may be required.?
For further information on this Staff Microbiologist role please contact Orla on 0860449473 / firstname.lastname@example.org
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