Quality Engineer Iii - Medical Device Manufacturing

Descripción y detalle de las actividades
The Quality Engineer III will lead complex quality initiatives, support regulatory compliance, and drive continuous improvement efforts in a fast-paced maquiladora environment. This role is ideal for a seasoned quality professional with strong problem-solving skills and deep knowledge of medical device regulations.
**Key Responsibilities**:
- Lead and support investigations for nonconformances, CAPAs, and customer complaints.
- Perform risk analysis, root cause analysis, and validation activities.
- Develop and improve quality systems in compliance with ISO 13485, FDA 21 CFR Part 820, and applicable regulatory requirements.
- Collaborate with cross-functional teams in manufacturing, engineering, and regulatory affairs.
- Conduct internal and supplier audits.
- Mentor and provide technical guidance to junior quality engineers.
- Drive continuous improvement projects and use of quality tools (Six Sigma, Lean, SPC, etc.)....