Medical Device Quality Inspector

Medical Device Quality Inspector
Perform inspections and ensure compliance with GMP and FDA standards in medical device manufacturing.

Job #136111

Manufacturing

Madison, Wisconsin

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Talascend is currently seeking a Medical Device Quality Inspector for a contract opportunity with our client in Madison, Wisconsin .


Overview


This role involves ensuring that materials, activities, processes, and conditions related to device manufacturing, processing, and packaging meet current GMP standards and comply with applicable procedures and standards. The inspector maintains compliance with quality systems and medical device regulations, supporting the quality assurance process across manufacturing operations.


Responsibilities

• Inspect raw materials to meet production requirements
• Conduct in-process inspections of manufacturing product and processes
• Review final documentation and shipment packaging for medical devices, subassemblies, and kits
• Assist in the Madison Manufacturing documentation control room
• Complete documentation of activities performed, prepare and attach material quality status labeling
• Ensure storage and handling of product and labeling in a controlled and secure manner
• Support quality through occasional investigations of nonconformance and assist with preventive actions
• Perform quality reviews for quarantine releases on non-reportable, non-complaint, RMF-3 internal to an RSC

Qualifications

• High school diploma or equivalent
• One year of experience in a regulated work environment preferred
• Knowledge of FDA Quality System Regulations and ISO 13485 pertaining to medical device manufacturing
• Demonstrated ability to perform the duties of this position through relevant experience, training, or education

We thank all applicants for their interest. However, only those qualified individuals who closely meet the qualifications of the position will be contacted. The details of the position are only a summary, other duties may be assigned as necessary.


Background Check and Drug Screen may be required.