Quality Assurance Specialist

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Corporate Quality Assurance Specialist
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 and18,000 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 servicesin 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 a Corporate Quality Specialist

This is a role well suited to an ambitious professional, looking for the next step in their career.

As a Corporate Quality Specialist, you will be responsible for:



* You will provide Quality oversight of the Production Support Lab, the Technical Support Team and Implementation Team.

These teams support US based sites that manufacture and distribute radioactive sterile injectables (PET) per 21 CFR Part 212 and USP 825 for Radiopharma.


* You will act as the Quality System Officer (QSO) for the listed corporate teams.


* You will assist the Corporate Quality group with root cause analysis and trend analysis of technical issues as needed (analytical equipment and manufacturing-related) to support GMP investigations and CAPA's.


* You will review GMP-related investigations, CAPA's, change controls, etc.

as assigned to ensure any technical components are accurate.


* You will serve as the subject matter expert on assigned topics providing input on policies, procedures and decisions related to those topics.


* You will participate in continuous improvement and trend analysis projects as assigned.


* Additional responsibilities include review of qualifications and other documentation, providing GMP training to corporate personnel as needed, and supporting audits and inspections as needed to support Radiopharma's Quality oversight functions.


* This is not a remote position; this position will be based in Knoxville, TN.

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



* You have experience in the pharmaceutical industry (preferably sterile drug manufacturing) and/or PET radiopharmaceuticals per 21 CFR Part 212 and Part 11 and/or USP 825


* You have at least 3 ye...