Job Description

Medical Device Quality Inspector

Madison WI

$25-$30 an hour

Contract role-12 months

About the Role

Responsible for assuring that materials, activities, processes, and specified conditions related to the daily device manufacturing, processing and packaging meet current GMP standards and comply with applicable procedures and standards such as ensuring the quality integrity of the product. Ensure work is completed in compliance with the company quality system and medical device regulations.

Responsibilities

• Inspecting raw materials to meet production requirements
• Conducts in-process inspection of manufacturing product and processes
• Reviews final documentation and shipment packaging for medical devices, subassemblies, and kits
• Assists in the Madison Manufacturing documentation control room.
• Completes documentation of activities performed, prepares and attaches material quality status labeling. Ensures storage and handling of product and labeling in a controlled and secure manner.
• Supports Quality through occasional conduct of investigations of nonconformance, assists with preventive actions associated with the QA unit.
• Performs quality reviews for quarantine releases on non-reportable, non-complaint, RMF-3 internal to an RSC.

Qualifications

• High School diploma or equivalent
• One year’s experience in a regulated work environment preferred
• Knowledge of FDA Quality System Regulations and ISO13485 pertaining to medical device manufacturing

Required Skills

• Attention to detail
• Strong analytical skills
• Ability to work in a team environment

Preferred Skills

• Experience in a medical device manufacturing environment
• Familiarity with quality control processes

Pay range and compensation package

$25-$30 an hour

Equal Opportunity Statement

We are committed to diversity and inclusivity in our hiring practices.

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