Quality Engineer 4 - Post Market Regulatory Immunoassay Commercial Product Quality

Job Description

At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably.  A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.

Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.

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 4 (Post Market Regulatory Compliance)

The primary responsibility of this function is to participate in the post market regulatory compliance and vigilance reporting for Siemens Healthineers Laboratory Diagnostics Immunoassays.  The position is within the Laboratory Diagnostics Quality organization and works closely with other functions. 

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

  • Lead cross functional teams toward product issue resolution, interaction and correspondence with FDA and OUS authorities regarding Medical Device Reports, recalls and requests for regulatory information
  • Review and approval of corrective actions related to customer complaints and field actions.
  • Assist in the preparation for and participation in external regulatory inspections and audits that occur at the Walpole site as well as, review and approval of promotional material.

Key Skills and Competencies for role:

  • Exhibits skillful written and verbal communication, works cooperatively with others and presents views in a convincing way.
  • Sees the big picture rather than a narrow focus of own specialization.  Questions assumptions and generates new ideas and approaches and follows through on implementation.
  • Makes independent, timely decisions, knowing when to consult vs. when to proceed. 
  • Communicates decisions effectively.
  • Able to effectively influence people within a multi-disciplinary environment.

The incumbent is a team player often suggesting compliant solutions to difficult situations.  Challenges include influencing people and the direction of projects without having direct reporting structure

Required skills to have for the success of this role

·       BS Degree with 8 – 10 years of relevant work experience

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.



Job ID: 195944

Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Inc.

Experience Level: Experienced Professional

Job Type: Full-time



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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, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.

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