Quality Inspector I – MPVS Turno C

About the role

The Quality Inspector I supports the production of medical device components by performing inspections and quality assurance activities on raw materials, in‑process parts, and finished products. The role ensures compliance with FDA QMS regulations, ISO 13485, and internal quality standards.

Key responsibilities

• Inspect incoming materials, in‑process components, and finished goods according to approved procedures, specifications, and sampling plans.
• Conduct visual, dimensional, and functional inspections using calibrated tools such as calipers, micrometers, and gauges.
• Review Device History Records, batch records, and other documentation for completeness and regulatory compliance.
• Identify, document, and escalate non‑conforming items; support segregation, containment, and non‑conformance reporting.
• Perform in‑process and final audits, record results in electronic or paper systems, and maintain Good Documentation Practices.
• Assist with line clearance, equipment calibration, cleanroom procedures, and support internal or external audits.
• Collaborate with Manufacturing, Engineering, and Quality Engineering to resolve quality issues and drive continuous improvement.

Required profile

• Working knowledge of GMP, GDP, and basic quality system requirements.
• Familiarity with FDA 21 CFR Part 820 and ISO 13485 standards.
• Ability to read and interpret engineering drawings, specifications, and inspection criteria.
• Strong attention to detail and ability to detect defects.
• Effective written and verbal communication skills.

Required skills

• Good Manufacturing Practices (GMP)
• Good Documentation Practices (GDP)
• FDA 21 CFR Part 820
• ISO 13485
• Use of inspection tools (calipers, micrometers, gauges)
• Measurement equipment operation
• Reading engineering drawings
• Basic sampling plans and inspection methods
• Microsoft Office
• Electronic quality management systems