Quality Professional

Company: Siemens Healthineers
Location: Mishawaka
Posted on: September 19, 2022

Job Description:

Job Family: Quality ManagementReq ID: 293573Nows 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 ProfessionalThis is a role well suited to an ambitious professional, looking for the next step in their career. As a Quality Professional, you will be responsible for :

• You will act as the Regulatory Affairs (RA) subject matter expert and coordinate regulatory projects, project schedules and the product introduction process in the site; participate in the decision-making process on regulatory submission issues
• In your activities you will identify, analyze, and implement U.S. country specific requirements necessary for product related medical device FDA submissions
• Healthineers internal or external organizations according to regulatory requirements
• You will create quality guidelines and work instructions relevant for maintaining site regulatory compliance
• You will coordinate with a group of quality related staff without leading the teamThis position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers
  • Deep professional know-how and experience U.S. Regulatory Affairs and solid professional judgment and problem-solving competence.
  • You have thorough understanding of MDSAP country standard requirements and regulatory authority for medical device or pharmaceutical operations
  • You have experience working in the manufacture of In-Vitro Diagnostic reagents and test kits
  • You have strong scientific, communication, and organizational skills are a must
  • You have experience with Microsoft Office Suite for administrative document manipulationRequired skills to have for the success of this role
    • BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience
    • Minimum of 3 - 5 years of experience in in Regulatory Affairs, preferably with a global manufacturer of IVD medical devices
    • Must have strong organizational and technical writing skills
    • Must have strong communication skills and work well with a team and experience working on multidisciplinary teams in a fast-paced, dynamic environmentAt 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.Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity. Going forward, please be aware that Siemens Healthineers requires full COVID-19 vaccination for all new hires by their start date except where prohibited by state law.(Note: Accommodations may be requested for certain medical or religious reasons)#LI-EM1Organization: Siemens HealthineersCompany: Siemens Healthcare Diagnostics Inc.Experience Level: Experienced ProfessionalFull / Part time: Full-timeEqual Employment Opportunity StatementSiemens 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 LawApplicants 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 ProvisionSiemens 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 NoticeCalifornia 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) .

Keywords: Siemens Healthineers, Mishawaka , Quality Professional, Other , Mishawaka, Indiana