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.