Quality & Complaints Analyst – Medical Devices

Enovis; Tijuana; Sur place; MXN 201 000 - 312 000; Plein temps

Résumé du poste

Enovis is seeking a QA specialist to perform quality assurance functions for product complaints, coordinating with customer service and distribution to gather data for investigations.

The role focuses on analyzing returned products, confirming defects, generating investigation reports, and proposing corrective actions within an Agile system to meet ISO 13485 standards in a medical devices environment. Strong English and experience with Oracle/Agile are preferred.

Qualifications

• 1-2 year of experience in complaint handling (preferably for medical industry).
• Advanced English level (perform fluid presentations, maintain conversation at a professional level, understanding and writing all information related to complaints).
• Experience with Oracle and Agile systems.
• Preference for background in Orthopedic Medicine, Medical Devices, or Physical Therapy.

Responsabilités

• Applies acquired job skills and procedures to complete assigned tasks.
• Monitor reception of returned products related to complaints.
• Analyze returned products (As required).
• Confirm or dismiss reported defect, thru the information gathered and results of inspection / analysis done by the Complaints Quality Inspector.
• Archive quality records related to quality, per applicable procedures.
• Generate investigation reports.
• Propose corrective actions to Quality Engineering group.
• Generate, analyze and distribute complaints report.
• Input complaints information in Agile system and follow-up to closure, on time and in full.
• Maintain applicable procedures up to date and ensure adherence to them.
• Track adherence to pre-defined KPIs.

Connaissances

Advanced English

Interpersonal skills

Communication skills

Complaint handling

Drawing interpretation

Risk assessments

Outils

MS Office

Oracle

Agile

Description du poste

Enovis is seeking a QA specialist to perform quality assurance functions for product complaints, coordinating with customer service and distribution to gather data for investigations.

The role focuses on analyzing returned products, confirming defects, generating investigation reports, and proposing corrective actions within an Agile system to meet ISO 13485 standards in a medical devices environment. Strong English and experience with Oracle/Agile are preferred.