at Siemens in Newark, Delaware, United States
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 3.
This is a role well suited to an ambitious professional, lookingfor the next step in their career. As a QualityEngineer 3 , you will be responsible for :
+ Inyour activities you will demonstrate subject matter expertise and theability to provide guidance in the areas of change control, validation,design controls, design transfer activities, risk management, CAPA, audit,and statistical analysis techniques.
+ Youwill serve as the SCM Quality Lead on Design Transfer and Change Controlprojects
+ Youwill participate in Change Control Review Board and Validation ReviewBoard
+ Youwill maintain validation procedures and records as well as providevalidation support (i.e. validation protocol drafting, approval,execution, train site personnel, etc)
+ Youwill identify opportunities for improvement for both internal and externalprocesses, lead continuous improvement initiatives, support problemsolving of complex production issues, and report on quality trends
+ Youwill independently perform full range of standard work as well as workcollaboratively with cross functional team members across the organization
This position may suit you best if you are familiar with whatis below, and would like to do develop your career with Healthineers
+ Youhave in depth working knowledge and practical application of processvalidation requirements (IQ,OQ, PQ) and Test Method Validation(TMV),change control, design controls, design transfer, risk management, CAPA,audit, and statistical process controls
+ Youhave in-depth knowledge of the requirements related to ISO 13485, FDA QSR,IVDR, and CGMP
+ Youhave proficient computer skills (MS Office Suite), statistical analysisskills using standard tools such as Microsoft Excel and Minitab, andorganizational skills
+ Youhave proven the ability to lead complex projects and work collaborativelywith others
+ Youhave experience problem solving and working in a fast-paced manufacturingenvironment
+ Youdemonstrate the ability to make decisions, prioritize, and communicateeffectively across multiple levels
+ Youstrive to continuously improve and are passionate about working in theMedical Device Industry
Required skills to have for the success of this role
+ Bachelor’sdegree in Engineering, Science, or equivalent experience required
+ Minimumof 5-8 years of successful experience in the Medical Device Industry andQuality Engineering
+ CertifiedQuality Engineer (CQE) or Six Sigma Certification preferred
+ Willingto travel up to 20%
Siemens Healthineers has recently announced the nextsteps in our continued commitment to prioritize colleague health, comply with customer/businesspartner requirements, and help preserve our business continuity. Goingforward, please be aware that Siemens Healthineers requires full vaccinationfor COVID-19 for our U.S. employees, contractors, and business partners, wherelocal conditions allow, who:
1) Are customer-facing (e.g., those required to visit acustomer/business partner site or interact in-person with customers at anyconference or meeting) OR
2) Come on-site, whether regularly or occasionally, atany Siemens Healthineers location.
(Note: Accommodations may be requested for certainmedical 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 isdelivered, 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.
EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm) .
Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\%20English\formattedESQA508c.pdf) .
California Privacy Notice
California residents have the right to receive additional notices about their personal information. To learn more, click here (https://new.siemens.com/us/en/general/legal/us-internet-privacy-notice-state-rights.html) .