Quality Engineer I (Operations)
ICU Medical • tijuana, Mexico
Role Description
Responsibilities
- Supports test method validation, PFMEA, and inspection activities to ensure product quality and process reliability.
- Collaborates with cross-functional teams to drive risk analysis, compliance, and continuous improvement.
- Develops and maintains quality documentation, including procedures, work instructions, and inspection methods.
- Generates and analyzes reports (e.g., FAI) to support product compliance and manufacturing readiness.
- Trains personnel on quality processes to ensure consistent adherence to requirements.
- Reviews and investigates product issues and/or customer complaints or other nonconformities, including quality system assessments, root cause determinations, and recommends corrective and preventive actions where required.
- Provides quality support for products and project development.
- Acts as a quality representative for quality issues in transfer products.
- Conduct ro...