What are the responsibilities and job description for the Medical Device Quality Inspector position at Stellar IT Solutions LLC?
Job Title : Medical Device Quality Inspector
Location : Madison, WI
Job Type : Contract - Long-Term
Industry : Medical Device Manufacturing
Reports To : Quality Assurance Manager
Job Overview :
We are seeking a Medical Device Quality Inspector to support our manufacturing operations by ensuring compliance with ISO 13485, FDA regulations, and internal quality standards. The Quality Inspector will conduct detailed part inspections, utilize precision measurement tools, and document findings in SAP and other quality management systems. The ideal candidate has experience in material inspection, quality control, and working within a regulated environment.
Key Responsibilities :
- Inspect parts and materials to ensure compliance with engineering drawings, specifications, and regulatory requirements.
- Perform inspections using measurement tools such as calipers, micrometers, thread gauges, plug gauges, and gage pins.
- Document inspection results in SAP and maintain nonconforming material reports.
- Identify defects and deviations and escalate issues as needed.
- Work within ISO 13485 and FDA regulated environments, following established procedures and documentation requirements.
- Collaborate with production, engineering, and quality teams to maintain product integrity.
- Support production operations and be flexible with assignments based on workflow and priorities.
- Work with Microsoft Word and Excel to maintain inspection records and generate reports.
- Be willing to work overtime based on production demands.
Qualifications :
