Quality Analyst

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

Who We Are

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit www.enovis.com.

What You'll Do

Performs functions associated with quality assurance operations. Analyzes Product Complaints and works with customer service and distribution partners to gather data for complaint investigations.

Essential Functions. Specific Responsibilities

• Applies acquired job skills and procedures to complete assigned tasks.
• Semi routine tasks and recognizes the occasional need to deviate from standard practice.
• Requires instructions on new tasks and general supervision.
• 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.

REQUIREMENTS: EXPERIENCE, EDUCATION, SKILLS, AND KNOWLEDGE.

Professional degree.

• 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).
• MS Office, Oracle, Agile.
• Knowledge in drawing interpretation, document control guidelines, risk assessments, BOMs, FMEAs, QSR ISO 13485:2016.
• Preferred background in Orthopedic Medicine, Medical Devices, or Physical Therapy.
• Strong interpersonal and communication skills required.
• Process and close complaints in Agile system.
• Creation and update of procedures, work instructions and visual aids related to Complaints.
• Execute internal audits (as applicable, if certified as internal auditor).
• Submit material transactions in Oracle.
• Create procedures, work instructions, visual aids, and other documents / forms in Agile.
• Stop operations due to safety risk or identification of quality noncompliance.
• Sign Quality-related records.
• Request and approve CAPAs.

EQUAL EMPLOYMENT OPPORTUNITY

Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees’ beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.