Quality Analyst - Agile Document Control & Compliance

Enovis Corporation; México; On-site; MXN 260,000 - 420,000; Full time

Job summary

Enovis Corporation, operating as DJO Mexico, is seeking a Quality Analyst to sustain the change control system (Agile) and support all document control activities in line with 21 CFR Part 820 and ISO 13485. The role involves routine and non-routine analysis of materials and finished products, data compilation, calibration of lab equipment, and preparation of investigations and reports.

The position requires 3+ years of related experience, a bachelor’s degree in administration or a related field,

Qualifications

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

Responsibilities

• Review, route, and release document and part change orders.
• Monitor status of in-process document changes for timely revisions.
• Create DOCs for periodic review SOPs; enter data into ERP after release.
• Ensure projects are completed accurately and on time; support audits.
• Provide Agile trainings as required.

Skills

Quality Assurance

Attention to detail

Education

Bachelor degree in administration or related field

Tools

ERP systems (Oracle)

Oracle

Agile tools

Job description

Enovis Corporation, operating as DJO Mexico, is seeking a Quality Analyst to sustain the change control system (Agile) and support all document control activities in line with 21 CFR Part 820 and ISO 13485. The role involves routine and non-routine analysis of materials and finished products, data compilation, calibration of lab equipment, and preparation of investigations and reports.

The position requires 3+ years of related experience, a bachelor’s degree in administration or a related field,