Quality Specialist (Change and Risk Management Lead)

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 (Change and Risk Management Lead)

This is a role well suited to an ambitious professional, looking for the next step in their career. As a Quality Specialist (Change and Risk Management Lead), you will be responsible for:

  • You will serve as the subject matter expert for the PETNET Change Management and Quality Risk Management (QRM) programs.
  • Serve as the change control/risk management liaison for corporate and sites, including ensuring all change control documentation is completed appropriately and required risk assessments are documented and approved prior to commencement of facility or equipment changes
  • Facilitator of interdisciplinary teams during risk assessments
  • Provide oversight and approval of site change controls and risk management activities
  • Primary support for IT related change/risk management initiatives
  • You will communicate regularly with corporate and site personnel pertaining to change/risk management issues and initiatives
  • Conduct site visits in support of significant facility changes or new builds, as needed
  • You will lead continuous improvement projects as assigned
  • Partner/team with stakeholders across the organization to address change control/risk management related issues and processes
  • Evaluate and approve proposed SOP changes and validation protocols/reports related to change/risk management processes
  • 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 scientist and/or engineer experienced in and focused on change control management and quality risk management in the medical device industry (21 CFR Part 820), or pharmaceutical industry (21 CFR Part 211), and/or PET radiopharmaceutical industry (21 CFR Part 212)
  • Experienced in development and management of change control related activities
  • Experienced in Quality Risk Management (QRM) tools and processes
  • You have good PC skills (MS Office software like Word, PowerPoint, Excel and Outlook)
  • You will be working with our latest technology and therefore you are willing to learn about new software and hardware solutions
  • You have very good facilitator and presentation skills

Required skills to have for the success of this role

  • Bachelor’s degree in Science/Engineering related field or equivalent experience required
  • Minimum of 5-8 years of change/risk management experience; preferably in a pharmaceutical related industry
  • Willing to travel up to 10%

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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Job ID: 196111

Organization: Siemens Healthineers

Company: PETNET Solutions, Inc.

Experience Level: Mid-level 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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