What are the responsibilities and job description for the Medical Device Quality Inspector position at Lenmar Consulting Inc?
Title: Medical Device Quality Inspector
Location: Madison, WI
Pay rate: $30/hr
Job Summary
The Medical Device Quality Inspector is responsible for ensuring that all materials, activities, processes, and specified conditions related to daily device manufacturing, processing, and packaging meet current Good Manufacturing Practice (GMP) standards. The core focus is on assuring the quality integrity of the product and compliance with the company's quality system and all applicable medical device regulations.
Essential Functions
The inspector performs one of the following three primary functions within the Quality department:
Inspecting Raw Materials: Verifying raw materials meet production requirements.
In-Process Inspection: Conducting in-process inspection of manufacturing products and processes.
Final Review and Packaging: Reviewing final documentation and shipment packaging for medical devices, subassemblies, and kits.
Additional Responsibilities
Assists in the Madison Manufacturing documentation control room.
Completes documentation of activities performed, prepares, and attaches material quality status labeling.
Ensures the storage and handling of product and labeling in a controlled and secure manner.
Supports Quality through occasional conduct of investigations of nonconformance and 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 is required.
One year’s experience in a regulated work environment is preferred.
Knowledge of FDA Quality System Regulations and ISO 13485 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 both individually and as a team member.
Good interpersonal skills; ability to communicate well, both verbally and written.
Working Conditions
Work is conducted within a manufacturing facility for medical devices and accessories, specifically in controlled environmental working conditions.
Location: Madison, WI
Pay rate: $30/hr
Job Summary
The Medical Device Quality Inspector is responsible for ensuring that all materials, activities, processes, and specified conditions related to daily device manufacturing, processing, and packaging meet current Good Manufacturing Practice (GMP) standards. The core focus is on assuring the quality integrity of the product and compliance with the company's quality system and all applicable medical device regulations.
Essential Functions
The inspector performs one of the following three primary functions within the Quality department:
Inspecting Raw Materials: Verifying raw materials meet production requirements.
In-Process Inspection: Conducting in-process inspection of manufacturing products and processes.
Final Review and Packaging: Reviewing final documentation and shipment packaging for medical devices, subassemblies, and kits.
Additional Responsibilities
Assists in the Madison Manufacturing documentation control room.
Completes documentation of activities performed, prepares, and attaches material quality status labeling.
Ensures the storage and handling of product and labeling in a controlled and secure manner.
Supports Quality through occasional conduct of investigations of nonconformance and 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 is required.
One year’s experience in a regulated work environment is preferred.
Knowledge of FDA Quality System Regulations and ISO 13485 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 both individually and as a team member.
Good interpersonal skills; ability to communicate well, both verbally and written.
Working Conditions
Work is conducted within a manufacturing facility for medical devices and accessories, specifically in controlled environmental working conditions.
Salary : $30
