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Regional Quality Compliance Specialist

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 a Quality Engineer (Internally referred to as Regional Quality Compliance Specialist or RQCS) 

This role can be remote based or in Knoxville, TN.

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

  • You will provide Quality oversight of multiple US based sites that manufacture and distribute radioactive sterile injectables (PET) per 21 CFR Part 212 and USP 825 for PETNET Solutions.
  • In your activities, you will focus on GMP Investigations and CAPA’s, change management and perform batch record and data integrity audits for assigned sites assuring PETNET’s Quality department is able to keep up with the growing business.
  • You will provide on-site support for the purposes of training/mentoring, performing internal and 3rd party quality audits and to host/support FDA inspections.
  • You will serve as the subject matter expert on assigned topics providing input on policies, procedures and decisions related to those topics.
  • You may participate in continuous improvement projects and conduct/support supplier audits

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 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 experience in interpreting regulatory policies and guidance documents and can 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
  • You have completed studies in Microbiology and/or Analytical Chemistry
  • You have good PC skills (MS Office software like Word, PowerPoint, Excel and Outlook)
  • You are willing to travel and be flexibility

Required skills to have for the success of this role

  • Bachelor’s degree or equivalent experience required
  • Excellent attention to detail
  • Be a creative problem solver with the ability to reprioritize multiple times per day while working at the speed of business and delivering results on time.
  • Willing to travel 25%-40%

Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity. Going forward, please be aware that Siemens Healthineers requires full vaccination for all new hires by their start date.

(Note: Accommodations may be requested for certain medical or religious reasons)

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.


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Organization: Siemens Healthineers

Company: Siemens Medical Solutions USA, Inc.

Experience Level: Experienced 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 unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.

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