Quality Assurance Analyst - Medical Devices

Enovis; Tijuana; On-site; MXN 260,000 - 380,000; Full time

Job summary

Enovis in Mexico is seeking a Quality Assurance professional to support complaint handling for medical devices. You will analyze product complaints, gather data with customer service, and drive investigations to closure.

Responsibilities include archiving records, generating investigation reports, proposing corrective actions, and updating procedures. A professional degree and 1–2 years in complaint handling are preferred; fluent English is required.

Qualifications

• 1-2 years of experience in complaint handling, preferably in medical devices.
• Advanced English level for presentations, professional conversations, and writing complaints.
• MS Office, Oracle and Agile familiarity.
• Knowledge in drawing interpretation, document control, risk assessments, BOMs, FMEAs, and ISO 13485:2016.
• Background in Orthopedic Medicine, Medical Devices, or Physical Therapy preferred.
• Strong interpersonal and communication skills are required.
• Experience in performing and closing complaints in Agile system.
• Ability to create and update procedures, work instructions and visual aids related to complaints.

Responsibilities

• Applies acquired skills to complete assigned tasks in QA operations.
• Analyzes product complaints and gathers data with customer service and distribution partners.
• Generates investigation reports and tracks KPI adherence.
• Archives quality records per procedures and archives.
• Inputs complaints information in Agile system and follows up to closure.
• Proposes corrective actions to Quality Engineering and supports CAPAs.
• Maintains applicable procedures and ensures adherence to them.

Skills

Advanced English

Interpersonal skills

Communication

Education

Professional degree

Tools

MS Office

Oracle

Agile

Job description

Enovis in Mexico is seeking a Quality Assurance professional to support complaint handling for medical devices. You will analyze product complaints, gather data with customer service, and drive investigations to closure.

Responsibilities include archiving records, generating investigation reports, proposing corrective actions, and updating procedures. A professional degree and 1–2 years in complaint handling are preferred; fluent English is required.