Medical Device Quality Inspector - Madison, WI

Lenmar Consulting, Inc.

Madison, WI

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JOB DETAILS

SALARY

$28–$30 Per Hour

SKILLS

Communication Skills, Corporate Compliance, Corrective Action, Detail Oriented, Documentation, FDA Requirements, GMP (Good Manufacturing Practices), Healthcare Quality, High School Diploma, ISO (International Organization for Standardization), Manufacturing, Manufacturing/Industrial Processes, Medical Equipment, Order Picking/Packing, Process Manufacturing, Quality Assurance, Quality Control, Regulations

LOCATION

Madison, WI

POSTED

30+ days ago

Title: Medical Device Quality Inspector
Location: Madison, WI
Duration: 6 months contract with extension up to 18 months and possible fulltime conversion
Pay rate range: $28/hr-$30/hr

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. Ensure work is completed in compliance with the company quality system and medical device regulations.

Essential Functions
• Performs one of three functions in the Quality department:
o Inspecting raw materials to meet production requirements
o Conducts in-process inspection of manufacturing product and processes
o 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.

Minimum Requirements
Education / Experience / Skills:
• 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

Competencies:
• High Level of motivation; ability to work independently
• Detailed oriented
• Ability to work with computer-based systems daily
• Collaborator with strong levels of engagement with individuals and as a team member
• Good interpersonal skills; ability to communicate well, both verbally and written

Working Conditions:
Manufacturing facility of medical devices and accessories. Controlled environmental working conditions.

About the Company

Lenmar Consulting, Inc.

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