Quality Engineer 4 - Commercial Product Quality

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 and Compliance Professional- Commercial Product Quality 4

This is a role well suited to an ambitious professional, looking for the next step in their career. As a Quality and Compliance Professional- Commercial Product Quality 4, you will be responsible for:

  • You will lead and drive to closure Product Quality Committee (PQC) and Field Action activities and decisions, as well as reporting to regulatory bodies as required for Siemens   Laboratory Diagnostics products.
  • You will represent and provide support for the Commercial Product Quality department when working  on post market compliance activities and issues primarily for the, Atellica CH and ADVIA Chemistry reagent and consumable Product Health teams,  as well as providing back up support for  Hardware/Software related issues from the Escalation Review Councils (ERC).
  • You will evaluate safety complaint escalations and make decisions on MDR reporting, fully documenting those decisions.
  • You will provide support in all areas associated with MDR/MDVR reporting and trending.
  • You will provide Commercial Product Quality support for external audits (MDSAP, FDA, etc.)

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 will be expected to perform at an advanced level in the field of Commercial Product Quality and apply advanced skills to resolve complex problems.
  • You will provide leadership to the Product Quality Committee in assessing and addressing product defects.
  • You will need to display a high level of critical thinking in bringing successful resolution to high-impact, complex, and/or cross-functional problems.
  • You must demonstrate a significant knowledge of organization’s business practices and issues faces and contributions to problem resolution of those issues.

Required skills to have for the success of this role

  • Experience in Quality Systems and Compliance, including CAPA, Medical Device Reporting, and Field Actions recommended
  • Good writing, communication and organizational skills necessary.
  • BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. 
  • 8 - 10 years of relevant experience preferred

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 Healthcare Diagnostics 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 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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