Medical Device Quality InspectorKellton Tech • Madison, WI, United States
Medical Device Quality Inspector
Kellton Tech • Madison, WI, United States
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job_description.job_card.job_descriptionHigh 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. 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. 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. 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.
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 :
Skills & Competencies :
Organizational Relationships & Scope :
Working Conditions :
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Quality Inspector • Madison, WI, United States
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