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.
Compile and report area metrics
Creating and/or updating area procedures to compile with Quality System
Additional project/responsibilities as required by the business needs
Required Knowledge/Skills, Education, and Experience
4-8 years of relevant experience or training in quality, production or final product inspection
Keen organizational skills and time management awareness
Must be able to work collaboratively with others in a team environment as well as with various departments
Knowledge of FDA regulated industry
Experience in Word, Excel and Powerpoint
Preferred Knowledge/Skills, Education, and Experience
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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