Quality Control Engineer

About the role

Dosentrx is a fast‑growing medical‑device company seeking a proactive Quality Control Engineer to support its Quality Management System. The role involves performing receiving, in‑process and final inspections, maintaining test equipment, and supporting CAPA investigations to ensure compliance with ISO 13485 and FDA 21 CFR 820.

Key responsibilities

• Conduct receiving inspection of incoming materials and components using defined forms.
• Perform in‑process and final product inspections according to Device Master Record specifications and acceptance test plans.
• Document non‑conforming items, support disposition decisions, and maintain accurate Device History Records.
• Maintain calibration and maintenance records for inspection, measuring and test equipment.
• Provide inspection data for CAPA investigations, root‑cause analysis and verification of corrective actions.
• Assist internal audits by supplying required records and participating in audit activities.
• Support supplier quality activities, including development of receiving inspection criteria and follow‑up on supplier corrective actions.
• Apply statistical sampling techniques and acceptance criteria to inspection activities.
• Collaborate with Production to identify recurring quality issues and support process‑level investigations.

Required profile

• Bachelor’s degree in engineering, quality or a related technical discipline, or equivalent experience.
• 1‑3 years of experience in quality control, inspection or manufacturing quality within a regulated environment; medical‑device experience preferred.
• Working knowledge of inspection techniques, sampling plans and test protocols.
• Familiarity with ISO 13485 and FDA QMSR (21 CFR 820) as applied to production and inspection.
• Experience with calibration and maintenance of inspection, measuring and test equipment.

Required skills

• Inspection techniques
• Sampling plans
• Test protocols
• Calibration of inspection equipment
• ISO 13485
• FDA 21 CFR 820
• Statistical sampling methods