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 60,000 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 is responsible batch record review and approval of raw, semi-finished and finished product materials in the manufacturing process.
Review of raw and semi-finished product batch records to ensure all requirements are met as well as compliance to ISO Standards and QSR prior to moving material to an approved status for use in commercial products.
Review of finished product batch records to ensure all release/specification requirements are met as well as compliance to ISO Standards and QSR regulations prior to releasing finished product material.
- Execute area reports
- Compile and report area metrics
- Creating and/or update area procedures to compile with Quality System
- Additional projects/responsibilities as required by the business needs
Required Knowledge/Skills, Education, and Experience
- High school diploma or equivalent required. AA degree in related field preferred
- 4-8 years of relevant experience or training in quality, production or final product inspection
- Understanding of ISO and QSR Regulations
- Strong verbal and written communication skills
- Keen organizational skills and time management awareness
- Must be able to read and interpret regulations and procedures
- Must be able to work collaboratively with others in a team environment as well as with various departments
- Knowledge of FDA regulated industry
- Detail oriented
- Experience in Word, Excel and Powerpoint
- SAP knowledge preferred
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.
(Note: Accommodations may be requested for certain medical 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 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.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Early Professional
Job Type: Full-time
Equal Employment Opportunity Statement
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