Business Unit: Diagnostics
Requisition Number: 247107
Primary Location: United States-California-Berkeley
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 10%
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 Systems Engineer, Molecular Services Business
This is a role
well suited to an ambitious professional, looking for the next step in their
career. As a Quality Systems
Engineer, you will be
- Documentation Control Management on an electronic QMS: Quality document lifecycle management
- Administering and maintaining compliant periodic review scheduling and reporting
- Driving quality initiatives to support CAP accredited/CLIA licensed Laboratory
- Managing CAPA and Complaint/Occurrence programs
- Developing metrics and reports, including Management Review
- Introducing, coaching and coordinating business improvements through training, new quality tool development, implementation, and authoring SOPs
- Conducting internal audits
- Applying audit readiness skills and techniques within the organization and participate in external regulatory or customer audits
This position may suit you best if you are familiar
with what is below, and would like to develop your career with
- You must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient
- You will need to be comfortable communicating with all levels of staff, including executives
- MasterControl documentation management experience strongly preferred
- 1-2 year training system implementation and control/administration or system owner Experience preparing for and participating in external QMS and regulatory audits a plus
- Complaint & CAPA handling experience
- Project management or leadership skills
- Regulatory submission experience a plus
Required skills to have for the success of this role
- BA/BS in a Natural Science (Biology, Molecular Biology, Chemistry, Biochemistry, etc)
- 5+ years’ experience in Quality roles within the Medical Device industry
- Electronic document management system control/administration and /or management experience, ideally in the Medical device Industry
- Software skills including Outlook, PowerPoint, WORD, EXCEL, etc
- Effective communication, collaboration, and strong technical writing skills
- Working knowledge of US/EU regulations and guidelines, including 21 CFR Parts 11, 803, 806, 820, ISO 13485, 15189, 42 CFR 193, IVDD, IVDR
- Must be able to work independently, interface effectively, and demonstrate a high level of reliability, integrity, and personal accountability, as a member of the quality management team
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.