Job Description

**Job Title: **Medical Device Quality Inspector

Location: Madison, WI

Pay Rate: $30/hr.

Position Summary:

The Medical Device Quality Inspector is responsible for ensuring that all materials, processes, and packaging activities comply with current GMP standards, FDA regulations, and company quality system requirements. This role plays a critical part in maintaining product integrity, safety, and compliance within a controlled manufacturing environment.

Essential Functions:

• Perform one or more of the following Quality Department functions:
• Assist in the Madison Manufacturing documentation control room.
• Complete documentation of inspection activities, prepare and apply material quality status labels, and ensure proper storage and handling of products and labeling.
• Support Quality by assisting with nonconformance investigations and preventive actions within the QA unit.
• Conduct quality reviews for quarantine releases on non-reportable, non-complaint, RMF-3 internal to an RSC.

Minimum Requirements:

Education & Experience:

• High School Diploma or equivalent required.
• Minimum of 1 year of experience in a regulated manufacturing environment preferred.
• Knowledge of FDA Quality System Regulations and ISO 13485 standards for medical device manufacturing.

Skills & Competencies:

• Highly motivated with the ability to work independently.
• Strong attention to detail and organizational skills.
• Proficient in the use of computer-based systems.
• Collaborative mindset; strong engagement both individually and within teams.
• Excellent verbal and written communication skills.

Organizational Relationships & Scope:

• Reports to the Quality Control Manager.
• Responsible for timely completion of investigative work and detailed reporting.
• Collaborates cross-functionally with Manufacturing, Engineering, and Quality teams to assess nonconforming products and support supplier quality efforts.

Working Conditions:

• Work performed in a medical device manufacturing facility under controlled environmental conditions.
• Regular exposure to cleanroom or production environments following standard safety and quality protocols.