Quality Analyst, Complaints & CAPA

DJ Orthopedics Services, SA de CV; México; On-site; MXN 360,000 - 520,000; Full time

Job summary

Enovis Corporation in Mexico is seeking a Quality Assurance professional to analyze product complaints and collaborate with customer service and distribution to gather data for investigations. You will apply procedures, monitor returned products, and generate reports while driving corrective actions with the Quality Engineering team.

You will ensure compliance with ISO 13485:2016, maintain procedures, and track KPIs, contributing to a robust quality system and timely closure of complaints.

Qualifications

• Professional degree.
• 1-2 years of experience in complaint handling (medical industry preferred).
• Advanced English; able to present, converse, and write all complaint-related info.
• Proficiency with MS Office, Oracle, and Agile.
• Knowledge of drawing interpretation, document control guidelines, risk assessments, BOMs, FMEAs, ISO 13485:2016.
• Preferred background in Orthopedic Medicine, Medical Devices, or Physical Therapy.
• Strong interpersonal and communication skills.
• Experience with Agile for closing complaints.
• Submit material transactions in Oracle.

Responsibilities

• Applies acquired job skills and procedures to complete assigned tasks.
• Monitor reception of returned products related to complaints.
• Analyze returned products.
• Generate investigation reports.
• Propose corrective actions to Quality Engineering group.
• Input complaints information in Agile system and follow-up to closure.
• Maintain applicable procedures up to date and ensure adherence.
• Track adherence to pre-defined KPIs.
• Create procedures, work instructions, visual aids, and other documents in Agile.
• Submit material transactions in Oracle.

Skills

Advanced English

Interpersonal skills

Communication

Risk assessment

Education

Professional degree

Tools

MS Office

Oracle

Agile

Job description

Enovis Corporation in Mexico is seeking a Quality Assurance professional to analyze product complaints and collaborate with customer service and distribution to gather data for investigations. You will apply procedures, monitor returned products, and generate reports while driving corrective actions with the Quality Engineering team.

You will ensure compliance with ISO 13485:2016, maintain procedures, and track KPIs, contributing to a robust quality system and timely closure of complaints.