Quality Engineer

Job Description

Quality Engineer

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 Engineer 3.

This is a role well suited to an ambitious professional, looking for the next step in their career. As a Quality Engineer 3, you will be responsible for:

  • In your activities you will demonstrate subject matter expertise and the ability to provide guidance in the areas of change control, validation, design controls, design transfer activities, risk management, CAPA, audit, and statistical analysis techniques.
  • You will serve as the SCM Quality Lead on Design Transfer and Change Control projects
  • You will participate in Change Control Review Board and Validation Review Board
  • You will maintain validation procedures and records as well as provide validation support (i.e. validation protocol drafting, approval, execution, train site personnel, etc)
  • You will identify opportunities for improvement for both internal and external processes, lead continuous improvement initiatives, support problem solving of complex production issues, and report on quality trends
  • You will independently perform full range of standard work as well as work collaboratively with cross functional team members across the organization

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 in depth working knowledge and practical application of process validation requirements (IQ,OQ, PQ) and Test Method Validation(TMV), change control, design controls, design transfer, risk management, CAPA, audit, and statistical process controls
  • You have in-depth knowledge of the requirements related to ISO 13485, FDA QSR, IVDR, and CGMP
  • You have proficient computer skills (MS Office Suite), statistical analysis skills using standard tools such as Microsoft Excel and Minitab, and organizational skills
  • You have proven the ability to lead complex projects and work collaboratively with others
  • You have experience problem solving and working in a fast-paced manufacturing environment
  • You demonstrate the ability to make decisions, prioritize, and communicate effectively across multiple levels
  • You strive to continuously improve and are passionate about working in the Medical Device Industry

Required skills to have for the success of this role

  • Bachelor’s degree in Engineering, Science, or equivalent experience required
  • Minimum of 5-8 years of successful experience in the Medical Device Industry and Quality Engineering
  • Certified Quality Engineer (CQE) or Six Sigma Certification preferred
  • Willing to travel up to 20%

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 COVID-19 for our U.S. employees, contractors, and business partners, where local conditions allow, who:

1) Are customer-facing (e.g., those required to visit a customer/business partner site or interact in-person with customers at any conference or meeting) OR

2) Come on-site, whether regularly or occasionally, at any Siemens Healthineers location.

(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

If you wish to find out more about the specific before applying, please visit:

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


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.

EEO is the Law
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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