Quality Assurance Inspector I – Medical Device Manufacturing
Viant Medical · Vega Baja
Descrição do cargo
About the role
The Quality Assurance Inspector I provides quality assurance support for inspection, manufacturing, and assembly of medical devices, ensuring compliance with FDA, GMP, and ISO13485 standards.
Key responsibilities
- Perform mechanical, electrical, and visual inspections of raw materials, in‑process parts, and finished assemblies according to drawings, specifications, and procedures.
- Document inspection results, sampling plans, and dispositions; reject non‑conforming items and stop production when necessary.
- Conduct in‑process dimensional checks using gauges, micrometers, calipers, and microscopes.
- Execute basic ERP transactions and support validation projects.
- Audit assigned areas to verify compliance with Viant’s quality procedures.
Required profile
- Associate degree or equivalent work experience; Bachelor’s in Natural Sciences preferred.
- 3 months to 1 year recent experience in the medical device industry, including exposure to molding operations.
- Proficiency in English and basic statistical knowledge.
Required skills
- Use of testing equipment such as pin gauges, snap gauges, micrometers, calipers, and microscopes.
- Interpretation of component specifications, drawings, and quality procedures.
- Technical writing and documentation using Office Windows, Excel, Access, PowerPoint.
- Basic arithmetic calculations and ERP data entry.
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Viant Medical
Vega Baja
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