Quality Systems Engineer

Siemens Healthineers' PETNET Solutions, a global PET radiopharmaceutical network, leads the way in industry expertise. Providing routine, reliable delivery of high-quality radiopharmaceuticals and services has established us as the trusted partner in PET imaging since 1996.

With more than 47 locations around the globe, Siemens Healthineers PETNET Solutions is the largest supplier of positron emission tomography (PET) radiopharmaceuticals, delivering more than 1,000,000 doses to more than 2,800 imaging centers worldwide, each year. Since 1996 we have delivered more than 6,000,000 doses worldwide.

Because we have the largest network of pharmacies, our pharmacies back each other up. This gives us a dose fulfillment rate of >99%. If you place an order with us, we are successful at dispensing the dose. That is confidence delivered. Check us out: https://www.siemens-healthineers.com/en-us/molecular-imaging/petnet

Join our team now at Siemens Healthineers as a Quality Systems Engineer

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

• 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.

• Develop, evaluate, and/or approve proposed SOP changes and validation protocols/reports.

• Facilitator of interdisciplinary teams during risk assessments

• Review/approval of Quality related investigations, variances, change controls, etc.

• Communicate with corporate and site personnel pertaining to change/risk management issues and initiatives.

• Lead continuous improvement projects as assigned.

• Primary support for IT related change/risk management initiatives

• Provide support to corporate departments for Quality related tasks.

• Partner/team with stakeholders across the organization to address change control/risk management related issues and 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 SOP development/review, continuous improvement projects, 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 problem solving, root cause analysis, and process improvement activities.

• Experienced in development and management of change control related activities.

• Experienced in Quality Risk Management (QRM) tools and processes.

• Experienced in Project Management.

• 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 Quality Systems 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: https://jobs.siemens-healthineers.com/careers

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

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

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PETNET

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