Job Title:ย Medical Device Quality Inspector
Location:ย Madison, WI (Onsite)
Pay Rate:ย $30/hr. on W2
Job Summary
The Medical Device Quality Inspector is responsible for ensuring that materials, processes, and activities involved in daily device manufacturing, processing, and packaging meetย current Good Manufacturing Practices (GMP)ย and comply withย ISO 13485ย and applicable quality standards. This position plays a key role in maintaining the quality integrity of medical device products through precise inspection and documentation.
Key Responsibilities
- Inspect parts according to engineering drawings and specifications.
- Perform dimensional inspections using precision tools such asย calipers, micrometers, gage pins, plug gages, and thread gages.
- Record acceptance data in theย SAP ERP systemย after inspection.
- Enter failure data intoย nonconforming material reports (NCMRs)ย when applicable.
- Support daily production activities and collaborate with the team to meet quality and output goals.
- Follow all established procedures in compliance withย FDAย andย ISO 13485:2008ย standards.
- Maintain documentation in accordance withย GMPย and company policies.
- Adapt to various inspection assignments and assist team members as needed.
- Work overtime when required based on production schedules and incoming part volumes.
Desired Experience
- Experience withย optical measurement machinesย or aย Coordinate Measuring Machine (CMM).
- Familiarity withย ISO 13485ย orย ISO 9001ย quality management systems.
- Prior experience withย material or component inspectionย in a regulated environment preferred.
- Exposure toย computer-based quality systems;ย SAP experienceย is a plus (training provided).
Qualifications
- Education:ย High School Diploma or equivalent.
- Language:ย Ability to read and write in English.
- Mathematical Skills:ย Basic math proficiency required.
- Technical Skills:
- Ability to use precision measurement tools such as calipers, micrometers, and thread gages.
- Proficiency withย Microsoft Word and Excel.
- Soft Skills:
- Strong attention to detail and defect identification.
- Ability to work efficiently in aย fast-paced team environmentย with minimal supervision.
- Flexibility to work overtime as required.
About the Role
This is a hands-on quality inspection position within aย team-oriented environmentย that supports manufacturing operations. The ideal candidate isย detail-oriented,ย computer-proficient, and eager to learn inspection procedures underย regulated (FDA and ISO 13485)ย conditions.