Medical Device Quality Inspector

Madison, OH - USA

Monthly Salary: Not Disclosed

Posted on: 30-10-2025

Vacancies: 1 Vacancy

Job Summary

Job Title: Medical Device Quality Inspector
Location: Madison WI 53718 USA
Department: Quality Control
Reports To: Quality Control Manager

Job Summary

The Medical Device Quality Inspector is responsible for ensuring that all materials processes and procedures related to device manufacturing processing and packaging comply with current Good Manufacturing Practices (GMP) and meet internal quality standards as well as the FDA Quality System Regulations and ISO 13485 standards. The role ensures the quality and integrity of medical devices through detailed inspections documentation reviews and adherence to regulatory requirements.

Essential Functions

Perform one or more key Quality Control functions:
- Raw Material Inspection: Verify incoming materials meet required production and quality standards.
- In-Process Inspection: Conduct in-process evaluations of products and manufacturing processes.
- Final Documentation Review: Review final packaging labeling and documentation for completeness and compliance.
Assist in documentation control activities within the manufacturing facility.
Accurately document all inspection and verification activities ensuring traceability and product labeling integrity.
Ensure secure and compliant storage and handling of materials and finished goods.
Support investigations of nonconformances and assist in preventive and corrective actions (CAPA).
Perform quality reviews for quarantine releases on non-reportable non-compliant internal RMF-3 events within the RSC.

Minimum Requirements

Education & Experience:

High school diploma or equivalent required.
Minimum of one (1) year of experience in a regulated manufacturing environment (medical device or pharmaceutical preferred).
Working knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485 standards.

Skills & Competencies:

Strong attention to detail and accuracy.
Highly motivated with the ability to work independently and collaboratively.
Competent in using computer-based quality and documentation systems.
Excellent interpersonal verbal and written communication skills.
Strong problem-solving and organizational abilities.

Working Conditions

Work is performed in a controlled manufacturing environment for medical devices and accessories.
The position may require standing for extended periods and performing detailed inspections under magnification or controlled lighting.
Strict adherence to environmental and safety regulations is required.

Required Skills:

Medical DevicesGMPManufacturing Automation

Job Title: Medical Device Quality InspectorLocation: Madison WI 53718 USADepartment: Quality ControlReports To: Quality Control ManagerJob SummaryThe Medical Device Quality Inspector is responsible for ensuring that all materials processes and procedures related to device manufacturing processing an...

Perform one or more key Quality Control functions:
- Raw Material Inspection: Verify incoming materials meet required production and quality standards.
- In-Process Inspection: Conduct in-process evaluations of products and manufacturing processes.
- Final Documentation Review: Review final packaging labeling and documentation for completeness and compliance.
Assist in documentation control activities within the manufacturing facility.
Accurately document all inspection and verification activities ensuring traceability and product labeling integrity.
Ensure secure and compliant storage and handling of materials and finished goods.
Support investigations of nonconformances and assist in preventive and corrective actions (CAPA).
Perform quality reviews for quarantine releases on non-reportable non-compliant internal RMF-3 events within the RSC.

Minimum Requirements

Education & Experience:

High school diploma or equivalent required.
Minimum of one (1) year of experience in a regulated manufacturing environment (medical device or pharmaceutical preferred).
Working knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485 standards.

Skills & Competencies:

Strong attention to detail and accuracy.
Highly motivated with the ability to work independently and collaboratively.
Competent in using computer-based quality and documentation systems.
Excellent interpersonal verbal and written communication skills.
Strong problem-solving and organizational abilities.

Working Conditions

Work is performed in a controlled manufacturing environment for medical devices and accessories.
The position may require standing for extended periods and performing detailed inspections under magnification or controlled lighting.
Strict adherence to environmental and safety regulations is required.

Required Skills:

Medical DevicesGMPManufacturing Automation