Overview
Medical Device Quality Inspector Jobs in Madison, WI at Equiliem
Medical Device Quality Inspector
Madison, WI
Pay: $24.00 – $26.00 per hour
Job Summary
The Medical Device Quality Inspector is responsible for ensuring that materials, manufacturing processes, activities, and product conditions meet current Good Manufacturing Practices (GMP) standards and comply with applicable procedures, quality systems, and medical device regulations. This role supports product quality and integrity by performing inspections, reviewing documentation, maintaining quality records, and assisting with quality investigations and corrective actions within a regulated manufacturing environment.
Job Responsibilities
- Inspect raw materials to ensure compliance with production requirements.
- Perform in-process inspections of manufactured products and processes to verify quality standards are met.
- Review final documentation and shipment packaging for medical devices, subassemblies, and kits.
- Support documentation control activities within the manufacturing environment.
- Complete required documentation of inspection activities and maintain accurate quality records.
- Prepare and apply material quality status labels while ensuring proper storage and handling of products and labeling in a controlled environment.
- Assist with investigations of nonconforming products and support preventive and corrective actions within the Quality Assurance function.
- Perform quality reviews related to quarantine releases for applicable internal materials.
- Collaborate with manufacturing, engineering, and quality teams to assess product quality issues and support supplier quality activities.
Job Requirements
- One year of experience working in a regulated manufacturing or quality environment preferred.
- High School diploma or equivalent required.
- Knowledge of FDA Quality System Regulations and ISO 13485 standards related to medical device manufacturing.
- Strong attention to detail and ability to accurately complete documentation.
- Ability to work independently while maintaining productivity and quality standards.
- Ability to use computer-based systems and quality documentation tools on a daily basis.
- Strong verbal and written communication skills.
- Ability to collaborate effectively with team members across multiple functions.
- Commitment to maintaining product quality, regulatory compliance, and operational excellence.
Education
- High School diploma or equivalent required.
Work Experience
- Experience in a regulated work environment preferred.
Pay: $24.00 – $26.00 per hour
Benefits:
- Dental insurance
- Health insurance
- Vision insurance
Application Question(s):
- Are you familiar with quality systems or regulatory standards such as GMP, FDA, or ISO 13485?
- Have you utilized measuring devices such as Calipers, Gauges and Micrometers ?
- Do you have at least 1 year of experience inspecting engineered products or medical devices?
Work Location: In person
Title: Medical Device Quality Inspector
Company: Equiliem
Location: Madison, WI
Category:
