Cis investigator (complaints investigator)

Requirements:
Education
Maximum of 30% completed in a university degree OR technical diploma in a STEM-related field (e.g., Engineering, Life Sciences, Health Sciences, Computer Science, etc.).

Experience:
At least 1 year of experience in similar positions, or an equivalent combination of education and experience.

Skills
Customer focus.
Quality-oriented.
Continuous improvement.

English Level
B2+ (written and spoken).
Knowledge (Junior Level)

Basic understanding of:

FDA regulations and basic requirements (e.g., 21 CFR Part 820, MDR/IVDR).
Quality System Regulation (QSR) principles.
NCI (Nonconformance Investigation) process and its role in product quality and patient safety.

What we're looking for:
Excellent customer service and customer-centered communication skills.
Planning and execution applied to the right priority for day-to-day tasks and ability to promptly identify and escalate any conflicts is required.
Previous participation in Problem-Solving sessions and understanding of Root Cause Analysis tools and methodologies is highly desirable (Ishikawa, 6M's, 5 Why's).
Support the investigation process by assisting with CAPAs, supporting and reviewing DHRs as needed, and contributing to Risk Documentation and Label Review activities, among others.
Knowledge of Operational Excellence principles, understanding, and previous experience with Process Improvement initiatives is a plus (Kaizen events or other).

Auxiliar, asistencial y otros

Técnico medio

Gestión de calidad

1 año de experiencia

1 Vacante