| Job alert | Jobs 1 - 10 of 795 |
Assembler
CathX Medical
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Sunnyvale, CA, 94088
... This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS). ESSENTIAL FUNCTIONS: Reads work orders, follows production drawings and sample assemblies, or receives verbal instructions ... - May 23
Senior Software Test Engineer - Applications
RefleXion
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Hayward, CA, 94540
... 2 years of experience testing FDA Class II or Class III medical device software. 2 years of experience testing PET imaging systems and PET emission sources. 2 years of experience working with diagnostic images. 2 years of experience working with ... - May 17
Quality Engineer IV
AbbVie
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Dublin, CA, 94568
... Work in a quality engineering FDA regulated Medical device manufacturing environment. Serve as quality leader on the production line, providing day-to-day oversight & guidance to manufacturing activities. Utilize knowledge of QSR & ISO 13485. Act as ... - May 16
MATERIAL SPECIALIST
Avinger, Inc
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Redwood City, CA, 94063
... Practices, and FDA regulations Ensure that all internal policies are followed Understand the job specific quality system procedures and processes as defined in the Training Matrix and adhere to the requirements listed in those documents. ... - May 01
Senior / Staff Manufacturing System Engineer - ONSITE
RefleXion
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Hayward, CA, 94540
... Designated an FDA Breakthrough Device for lung tumors, RefleXion's SCINTIX biology-guided radiotherapy aims to overcome long-standing barriers preventing definitive radiotherapy for metastatic disease. FDA-cleared SCINTIX therapy automates targeting ... - May 20
Supplier Quality Specialist
Weee
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Fremont, CA
... Responsibilities Manage foreign supplier onboarding and conduct supplier qualification review Perform direct import product reviews for food safety, quality, and labeling Coordinate USDA and FDA inspection and testing of imported products ... - May 08
Manufacturing Technician, Assembly Technician Medical Devices
QAPEL MEDICAL INC
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Fremont, CA, 94538
... Performs daily manufacturing inspection and testing of products to ensure they meet specifications and FDA requirements required. Maintaining legible and accurate records is required. Daily communication with the manufacturing team members, ... - May 08
Process Development Associate
Bayside Solutions
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Hayward, CA, 94557
... for clarifications and proposes improvements to ensure the quality of end product Preferred Skills: Familiarity with GMP, GLP, and FDA requirements in biotechnology Comfortable navigating technical documents (batch records, validation reports) and ... - May 18
Manager, Food Safety Program - Corporate - US
SYSCO
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Fremont, CA, 94537
unknown
... Ensure compliance with applicable food safety regulatory requirements (Federal, State/Provincial and, Local) including US FDA Seafood HACCP, FSMA Preventive Controls for Human Foods, FSVP, 204 Traceability Rule, USDA National Organic Regulations, ... - May 24
Sr. Regulatory Affairs Specialist
Hired by Matrix
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Palo Alto, CA, 94304
... Product Registration Experience: Experience with FDA 510(k) applications, Health Canada license applications and EU MDR technical files. Knowledge of regulatory guidance documents and requirements for product classification determination, FDA 510(k) ... - May 17