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Medical Device Quality Inspector

Medical Device Quality Inspector

Kellton TechMadison, WI, United States
30+ days ago
Job type
  • Full-time
  • Quick Apply
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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    Quality Inspector • Madison, WI, United States

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