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Quality Specialist - Medical Devices, Complaint Handling

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 60,000 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, Complaint Handling  on the Post Market Surveillance team

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

  • All aspects of complaint management, specifically assessing complaints for potential safety issues, investigating customer complaints, filing MDRs and Vigilance Reports, working with cross functional teams to determine root cause, and reviewing/closing complaint files
  • Ensuring compliance with all post market activities with regard to complaint processing and investigations, heath risk evaluations, field corrective actions and CAPAs
  • Chair post market surveillance teams to assign investigation leads, track investigation progress and ensure root cause determination.
  • Drive product investigations to obtain thorough root cause analyses
  • Report post market surveillance metrics on a periodic basis.
  • Respond to audit issues, and questions generated internally and externally regarding customer complaints.

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

  • FDA 21 CFR 820, 803 and ISO13485, EU MDR / MDD, and other global requirements in post market surveillance
  • Strong project management skills. 
  • Effective writing and communication skills.
  • Proactively reviewing the quality system and participating in special projects with a focus on continuous improvement of the Post Markey Surveillance system
  • Assisting with the coordination of external audits from regulatory authorities
  • Staying current with applicable regulations, quality standards/systems for all company products and markets

Required skills to have for the success of this role

  • Bachelor’s degree or equivalent experience required
  • Minimum of 5+ years of experience working in medical device post market surveillance activities, with strong emphasis on medical imaging software
  • Experience in other Quality System elements a plus.
  • Good working knowledge of FDA and international medical device regulations

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 COVID-19 vaccination for all new hires by their start date except where prohibited by state law.

(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 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.



Organization: Siemens Healthineers

Company: Siemens Medical Solutions USA, Inc.

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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