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
This is what truly matters to us. Join our team now at Siemens
Healthineers as Quality and Compliance Professional-Commercial
Product Quality 4.
This is a role well suited to an ambitious professional, looking
for the next step in their career.
As a Quality and Compliance Professional- Commercial Product
Quality 4 you will be responsible for :
Leading and driving to closure Product Quality Committee (PQC)
and Field Action activities and decisions, as well as reporting to
regulatory bodies as
required for Siemens Laboratory Diagnostics products.
You will represent and provide support for the Commercial
Product Quality department when working on post market compliance
activities and issues
primarily for the, Atellica CH and ADVIA Chemistry reagent and
consumable Product Health teams, as well as providing back up
support for Hardware/Software related issues from the Escalation
Review Councils (ERC).
You will evaluate safety complaint escalations and make
decisions on MDR reporting, fully documenting those decisions.
You will provide support in all areas associated with MDR/MDVR
reporting and trending.
You will provide Commercial Product Quality support for external
audits (MDSAP, FDA, etc.)
This position may suit you best if you are familiar with what is
below, and would like to do develop your career within Siemens
Healthineers. You will be expected to perform at an advanced level
in the field of Commercial Product Quality and apply advanced
skills to resolve complex problems.
You will provide leadership to the Product Quality Committee in
assessing and addressing product defects.
You will need to display a high level of critical thinking in
bringing successful resolution to high-impact, complex, and/or
You must demonstrate a significant knowledge of organization's
business practices, issues presented and contribute to problem
resolution of those
Required skills to have for success in this role:
Experience in Quality Systems and Compliance, including CAPA,
Medical Device Reporting, and Field Actions recommended.
Good writing, communication and organizational skills
BS/BA in related discipline, or advanced degree, where required,
or equivalent combination of education and experience.
8 - 10 years of relevant experience preferred.
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 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.
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