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:
• Inspect raw materials to meet production requirements.
• Conduct in-process inspections of manufacturing products and processes.
• Review final documentation and shipment packaging for medical devices, subassemblies, and kits.
• 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.

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