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MATERIAL SPECIALIST

Avinger, Inc  –  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

Manufacturing Engineering Manager

Avails Medical, Inc.  –  Menlo Park, CA
... This person should demonstrate a deep understanding of FDA regulations, specifically for Class II IVD products, and will be proficient in ISO 13485 standards for medical devices. Key Responsibilities: Serve as primary engineering contact for ... - May 05

Document Control Specialist

Digital Prospectors  –  Redwood City, CA, 94063
... Knowledge of Quality Assurance principles (i.e., ISO 9001, ISO 13485, and FDA cGMP regulations) is preferred. POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive ... - May 03

Document Control Specialist

Digital Prospectors  –  Redwood City, CA, 94063
... Knowledge of Quality Assurance principles (i.e., ISO 9001, ISO 13485, and FDA cGMP regulations) is preferred. POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive ... - May 03

Quality Inspection Tech (Contract)

a Medical Device company based out of Palo Alto,  –  Palo Alto, CA, 94306
... Inspecting Engineering Parts, performed 1st article inspection, in process inspection, final inspection on finish goods and did inspection of FDA class III medical devices HeartMate II LVAD pump. Generating non-conforming material reports (NCMRs) ... - Apr 25

Regulatory Affairs Manager

EPM Scientific  –  San Jose, CA
... You will be responsible for developing and implementing regulatory strategies to obtain market authorization from the FDA, including 510(k) clearances and PMAs. Responsibilities: Lead the regulatory strategy for our catheter device portfolio, with a ... - Apr 28

FSQA Tech

SYSCO  –  Fremont, CA, 94537
unknown
... QUALIFICATIONS Education Formal job training in TQM principles, SPC, HACCP concepts, CFIA/FDA regulations would be beneficial. Formal quality and sensory analysis training would be helpful. Experience One to 3 years of meat and/or seafood industry ... - Apr 29

Clinical Statistician II - A

DivIHN Integration Inc  –  Santa Clara, CA, 95054
... collaborate with the medical groups to complete joint scientific reports and FDA overviews, including review of such reports to ensure accuracy and clarity. May also contribute to the decision for optimal study design and contribute to the proper ... - May 04

Vice President Operations

Bone Health Technologies  –  Redwood City, CA, 94061
... Regulatory Compliance: Ensure compliance with all relevant regulatory requirements, including FDA regulations and ISO standards, to uphold the highest standards of quality and safety. Budget Management: Develop and manage departmental budgets, ... - Apr 21

Associate Quality Engineer

Bayside Solutions  –  Santa Clara, CA, 95053
... In the event of potential non-compliance with applicable standards or regulations (e.g., FDA QSRs, ISO 13485, or ISO 14971), the employee has the authority to hold any product or Quality documentation from shipment or further processing. The ... - Apr 27
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