Quality Specialist (Microbiology Data Analyst)

Job Description

Now’s our time to inspire the future of healthcare together.

Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.

Join our team now at Siemens Healthineers as Quality Specialist (Microbiology Data Analyst)

This is a role well suited to an ambitious professional, looking for the next step in their career. As a Quality Specialist (Microbiology Data Analyst), you will be responsible for:

  • You will serve as the owner and subject matter expert for the Environmental Monitoring Tracking and Reporting systems.
  • Evaluate and analyze environmental monitoring data from all PETNET sites to identify outliers and trends
  • Support the review of and provide data for environmental monitoring investigations from all PETNET sites
  • You will serve as a member on the Sterility Assurance Team
  • Support the review of and provide data for all sterility investigations
  • Review proposed SOP changes and validation protocols/reports related to sterility assurance and environmental monitoring
  • You will support continuous improvement projects as assigned
  • Support internal audits as assigned
  • Support supplier audits for sterile material suppliers and microbiological laboratories as assigned
  • Support regulatory inspections as needed
  • Other quality/regulatory related duties as assigned/needed

This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers

  • You are a microbiologist/scientist experienced in environmental monitoring and sterility data analysis in the pharmaceutical industry (21 CFR Part 211) and/or PET radiopharmaceuticals industry (21 CFR Part 212)
  • Experienced in the review and analysis of microbiological data, especially identifying outliers and trends that require immediate attention
  • You have excellent PC skills (MS Office software like Word, PowerPoint, Excel and Outlook)
  • Ability to interpret Regulatory policies and guidance documents and correctly apply them as appropriate to related activities
  • You can identify procedural gaps and product risk and where appropriate, recommend contingency plans and strategies to mitigate compliance risks
  • You are organized and an excellent communicator

Required skills to have for the success of this role

  • Bachelor of Science degree in a science related field or equivalent experience
  • Quality Engineer and/or data analysis experience preferred
  • Strong work ethic
  • Little to no travel required.  Corporate Knoxville based position.

At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose:  To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.

If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.

If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.

As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.


Job ID: 196110

Organization: Siemens Healthineers

Company: PETNET Solutions, Inc.

Experience Level: Early Professional

Job Type: Full-time

Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.

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