Business Unit: Ultrasound
Requisition Number: 246878
Primary Location: United States-Washington-Issaquah
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 5%
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.
This position has responsibility for manufacturing quality system compliance, including compliance to production and process controls, process validation, and non-conforming product requirements. Is a statistical expert and is a consultant to the organization on applicable statistical methodology.
The candidate must have experience with FDA QSR and ISO13485 requirements, experience in the manufacturing systems and statistical analysis.
- Ensure that manufacturing systems maintain compliance to external regulatory requirements and internal procedural requirements.
- Actively engage manufacturing engineering regarding process validation and ensure processes are adequately validated including a review of validation methodology, sample size determination, and results of process validation meet requirements.
- Participate in the development and changes, including review and approval, of process FMEAs applicable to the manufacturing site.
- May review and approve supplier control plans, FMEAs, and provide nonconformance feedback to suppliers through the Supplier Corrective Action (SCAR) system.
- Review and approve engineering changes applicable to specific manufactured products.
- Review and modify the current control processes for non-conformances to ensure that such processes continuously reflect current regulatory requirements and are in alignment with Siemens Healthineers CAPA policies.
- Proactively reviews the non-conformance control systems and participates in special projects related to the continuous improvement of this aspect of the quality system.
- Use statistical methodology for control charts, hypothesis testing, design of experiments and other methods to control and improve processes.
- BA/BS required and specialized Quality Systems training preferred.
- Five (5) plus years of experience working in a GMP regulated industry and good working knowledge of FDA and international medical device regulations with three (3) plus years in manufacturing of medical devices; Effective writing and communication skills.
- ASQ CQE or other certifications a plus.
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.