Quality Systems Engineer (eDMS)

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 66,000 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 Systems Engineer, Siemens Healthcare Laboratory

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:

  • Documentation administration on an electronic QMS: Quality document lifecycle management
  • eDMS upgrade implementation and validation
  • Administering and maintaining compliant periodic review scheduling and reporting
  • Driving quality initiatives to support CAP accredited/CLIA licensed Laboratory
  •  Managing CAPA and Complaint/Occurrence programs
  • Developing metrics and reports, including Management Review
  • Introducing, coaching and coordinating business improvements through training, new quality tool development, implementation, and authoring SOPs
  • Support of Customer supplier questionnaires, regulatory and customer audits
  • Conducting internal audits
  • Applying audit readiness skills and techniques within the organization and participate in external regulatory or customer audits

This position may suit you best if you are familiar with what is below, and would like to develop your career with Healthineers

  • You must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient
  • You will need to be comfortable communicating with all levels of staff, including executives
  • MasterControl Super Admin experience required
  • 1-2 year training system implementation and control/administration or system owner  Experience preparing for and participating in external QMS and regulatory audits a plus
  • Complaint & CAPA handling experience
  • Project management or leadership skills

Required skills to have for the success of this role

  • BA/BS in a Natural Science (Biology, Molecular Biology, Chemistry, Biochemistry, etc)
  •  8+ years’ experience in Quality roles within the Medical Device industry or Pharmaceutical Industry
  • Electronic document management system control/administration and management experience, ideally in the medical device Industry
  • Software skills including Outlook, PowerPoint, WORD, EXCEL, etc
  • Experience in software validation
  • Effective communication, collaboration, and strong technical writing skills
  • Working knowledge of US/EU regulations and guidelines, including 21 CFR Parts 11
  • Must be able to work independently, interface effectively, and demonstrate a high level of reliability, integrity, and personal accountability, as a member of the quality management team

Preferred skills to have for the success of this role

  • Working knowledge of US/EU regulations and guidelines, including 21 CFR Parts 803, 806, 820, ISO 13485, 15189, 42 CFR 193, IVDD, IVDR
  • Working knowledge of reference laboratory for CAP / CLIA and New York state requirements

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

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 Laboratory, LLC

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.

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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