Quality & Documentation Specialist (Agile)

Enovis; México; On-site; MXN 360,000 - 480,000; Full time

Job summary

Enovis seeks a detail-oriented professional to sustain the change control system and support document control activities in line with ISO 13485 and 21 CFR Part 820. You will analyze materials, support investigations, and help maintain SOPs while ensuring data integrity.

You will coordinate with quality and regulatory teams, perform routine audits, and contribute to process improvements in a fast-paced medical device environment.

Qualifications

• 3+ years related experience in document control or quality systems.
• Knowledge of FDA GMPs, ISO 13485 and applicable regulations.
• Proficient in Excel, Word, and Outlook; ERP experience a plus.

Responsibilities

• Review, route, and release document and part change orders.
• Monitor status of in-process document changes to ensure timely revisions.
• Create DOCs for periodic review SOPs; enter data into ERP after release.
• Assist in audits and ensure data quality and compliance with cGMPs.
• Provide Agile trainings as required.

Skills

Document control

Quality systems

Data analysis

Office suite

Education

Bachelor degree in administration or related career

Tools

ERP

Oracle

Agile

Job description

Enovis seeks a detail-oriented professional to sustain the change control system and support document control activities in line with ISO 13485 and 21 CFR Part 820. You will analyze materials, support investigations, and help maintain SOPs while ensuring data integrity.

You will coordinate with quality and regulatory teams, perform routine audits, and contribute to process improvements in a fast-paced medical device environment.