Quality Engineer I - Medical Devices | CAPA & QMS

Cirtec Medical Corp.; Rock Hill (SC); Vor Ort; USD 65.000 - 90.000; Vollzeit

Zusammenfassung

Cirtec Medical Corporation in Rock Hill, SC, seeks a Quality Engineer to monitor and audit quality of all manufactured goods for our medical device programs.

You will analyze root causes, implement CAPAs, and support continual improvement with cross‑functional teams.

Responsibilities include coordinating sample submissions, maintaining FAI/FMEAs, and supporting audits to ensure ISO 13485 compliance.

Qualifikationen

• Bachelor's degree in a technical/engineering field (STEM) is required.
• 0-2+ years of QA in a manufacturing environment preferred.
• Knowledge of GD&T, DOE, GR&R is needed.
• Familiarity with ISO 13485 quality systems is required.

Aufgaben

• Conduct root cause analysis and implement corrective actions (CAPAs).
• Support continual improvement activities with cross-functional teams to enhance the quality system.
• Coordinate transfer to production of new products per approved data; ensure compliance.
• Coordinate and prepare sample submission packages; update FAI and FMEAs; maintain Process Control Plans.

Kenntnisse

Bachelor's degree STEM

QA manufacturing 0-2 yrs

GD&T

DOE

GR&R

ISO 13485 knowledge

MS Office

Communication

Ausbildung

Bachelor's in Engineering or STEM

Tools

MS Office

Jobbeschreibung

Cirtec Medical Corporation in Rock Hill, SC, seeks a Quality Engineer to monitor and audit quality of all manufactured goods for our medical device programs.

You will analyze root causes, implement CAPAs, and support continual improvement with cross‑functional teams.

Responsibilities include coordinating sample submissions, maintaining FAI/FMEAs, and supporting audits to ensure ISO 13485 compliance.