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Quality Engineer 4 - Medical Device Post Market Compliance

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 a Quality Engineer 4.

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:

 *Participate in the post market regulatory compliance and vigilance reporting for Siemens Healthineers Laboratory Diagnostics Immunoassays.

*Leading 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, and review and approval of corrective actions related to customer complaints and field actions.

*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.

The position is within the Laboratory Diagnostics Quality organization and works closely with other functions.

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 Education, Skills & Experience:

*Bachelor's degree in a Science related discipline.

*8 - 10 years of experience

*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.

All employees must be fully vaccinated for COVID-19 by their start date.  If you need an accommodation for medical or religious reasons, please send an email to shshraccommodationsrequest.func@siemens-healthineers.com to ask for either the medical or religious reasonable accommodation request form.  Additionally, you will be required to report your vaccination status using TrueNorth, a secure and confidential online third-party platform for collecting health data, within 3 days of your start date.

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.

Why you’ll love working for Siemens Healthineers

  • Be part of exciting and innovative projects that help solve some of the world’s most significant health problems.
  • Engaging, challenging, and fast evolving, cutting edge technological environment.
  • Opportunities to advance your career.
  • Competitive total rewards package.
  • Contribute to our social responsibility initiatives focused on access to education and technology, and sustainability, making a positive impact on communities.
  • Participate in our celebrations and social events.
  • Opportunities to contribute your innovative ideas and get paid for them!
  • Employee perks and discounts.

We are globally recognized as an Employer of Choice, but don’t just take our word for it. Here are some of our most recent awards and recognition:

  • Great Place to Work Certified 2021
  • Best Places to Work for LGBTQ Equality
  • Best for Vets Employers by Military Times
  • Glassdoor Employer Rating: 4.0

Review our Benefits Summary:

Explore the Siemens Benefits QuickStart https://benefitsatshs.com/  website to learn about our competitive Benefits plans which we proudly offer to our regular full-time employees. The QuickStart website can be accessed by clicking the link above or by copying and pasting it into your web browser’s address bar and selecting “Thinking of Joining Siemens” to the left of the page.

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 specifics 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 Healthcare Diagnostics 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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