Quality Engineer I – Medical Devices & CAPA

Cirtec Services GmbH; Rock Hill (SC); On-site; USD 65,000 - 90,000; Full time

Job summary

Cirtec Medical Corporation is seeking a Quality Engineer to monitor and audit quality across manufactured goods for medical devices. You will analyze root causes, drive CAPAs, and partner with Engineering and Operations to ensure product quality and successful transfers to production.

The role requires a STEM degree, 0–2+ years of QA in manufacturing, and strong knowledge of GD&T, FMEA, DOE, and ISO 13485. Join a team focused on continuous improvement and regulatory compliance.

Qualifications

• Must have knowledge of GD&T, FMEA, DOE, and GR&R.
• Ability to read and interpret engineering drawings, schematics, and specifications.
• Familiarity with ISO 13485 quality systems.
• Excellent verbal and written communication skills.

Responsibilities

• Conduct root cause analysis and implement corrective actions for process/product concerns.
• Pursue continual improvements to enhance the quality system with cross-functional teams.
• Coordinate transfer to Production of new products in accordance with approved data.
• Support NPI activities with Engineering, Sales, and Customers.
• Prepare submission packages and maintain validation artifacts (FAI, PFMEA, Process Controls).
• Investigate non-conformances and recommend corrective actions to prevent recurrence.
• Assist quality inspectors to ensure compliance with QMS requirements.
• Conduct audits, close findings, and drive CAPAs under medical device quality standards (ISO 13485, CFR 820).
• Analyze failures and implement CAPAs to address customer complaints.
• Create and maintain quality documentation and reports.

Skills

GD&T

FMEA

DOE

GR&R

Engineering drawings

ISO 13485

Statistical Process Control

MS Office

Education

Bachelor's Degree in Engineering

Tools

MiniTab

Job description

Cirtec Medical Corporation is seeking a Quality Engineer to monitor and audit quality across manufactured goods for medical devices. You will analyze root causes, drive CAPAs, and partner with Engineering and Operations to ensure product quality and successful transfers to production.

The role requires a STEM degree, 0–2+ years of QA in manufacturing, and strong knowledge of GD&T, FMEA, DOE, and ISO 13485. Join a team focused on continuous improvement and regulatory compliance.