Senior Quality Engineer
Mishawaka, USA IT development
Job description
Do you want to join us in helping to fight the world’smost threatening diseases and enabling access to care for more people aroundthe world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere.
We offer you a flexible and dynamic environment withopportunities to go beyond your comfort zone in order to grow personally andprofessionally. Sound interesting? Then come and join our global team as Quality Engineer to help provide qualityengineering support for manufacturing, ensure that the quality of suppliedmaterials are maintained and meet specification requirements, conduct supplierquality audits, drive supplier corrective actions to resolution, create qualityinitiatives for reducing in- process/finished goods scrap, and transfer analogprocesses to digital platforms.
Our global team:We are a team of 66,000 highly dedicated employees across more than 70countries passionately pushing the boundaries of what’s possible in healthcareto help improve people’s lives around the world. As a leader in the industry,we aspire to create better outcomes and experiences for patients no matterwhere they live or what health issues they are facing. Our portfolio, spanningfrom in-vitro and in-vivo diagnostics to image-guided therapy and innovativecancer care, is crucial for clinical decision-making and treatment pathways.
Our culture:We are part of an incredible community of scientists, clinicians, developers, researchers,professionals, and skilled specialists pushing the boundaries of what’spossible, to improve people’s lives around the world. We embrace a culture of inclusivity in whichthe power and potential of every individual can be unleashed. We spark ideasthat lead to positive impact and continued success. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers.
This is a role well suited to an ambitiousprofessional, looking for the next step in their career. As a Quality Engineer,you will be responsible for:
- Create quality initiatives to improve in-process and finished good scrap
- Drive process control and monitoring improvements
- Maintain site supplier controls
- Proactively support the commodity network and supplier evaluation
- Support cross-functional cooperation between Procurement, Quality, Logistics, and Engineering, and Operations
- Ensure statistically valid sampling plans at all phases of operations
- Ensure test and inspection methods are properly validated
- Ensure that test and inspection methods address Critical to Quality requirements from the dFMEA and pFMEA requirements
- Develop and implement improved test and inspection procedures and methods
- Transfer analog processes to digital platforms.
- Support process validation activities
This position may suit you best if you are familiarwith what is below, and would like to do develop your career withHealthineers
- Performing supplier audits and driving supplier corrective actions to resolution
- Ensure quality compliance to all regulatory standards
- SAP QM function experience
- Agile Practices
- Power BI experience
Required skills to have for thesuccess of this role
- The successful candidate will possess a B.S. in science/engineering.
- The candidate will have an advanced knowledge of MDSAP, FDA, and ISO 13485 Quality Management Systems and have applied them to the workforce.
- Seeking immunoassay experience with microfluidics, protein chemistry, and ELISA.
- 5+ years of experience in projects involving cross-functional teams
- 5+ Years within a regulated industry
- 2+ years of experience in data mining using databases in a business environment with large-scale, complex datasets
- Possess effective written and verbal communication skills
- Strict attention to detail
- Driven by impact and is focused on results
- Acts as an entrepreneur and embodies a ownership culture
AtSiemens Healthineers, we value those who dedicate their energy and passion to agreater cause. Our people make us unique as an employer in the med-techindustry. What unites and motivates our global team is the inspiration of ourcommon purpose: To innovate forhealthcare, building on our remarkable legacy of pioneering ideas thattranslate into even better healthcare products and services. We recognize thattaking ownership of our work allows both us and the company to grow. We offeryou a flexible and dynamic environment and the space to move beyond yourcomfort zone to grow both personally and professionally.
“Successful candidate must be able to work with controlled technology in accordance with US export control law.” “It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce
If you want to join us in transforming the way healthcareis delivered, visit our career site at https://usa.healthcare.siemens.com/careers.
Ifyou 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 toconsider applications from individuals with disabilities.
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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