Design Quality Engineer - Medical Devices | Regulatory

Zimmer Biomet

Bogotá ciudad

On-site

COP 60,000,000 - 120,000,000

Full time

3 days ago

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Job summary

Zimmer Biomet is seeking a Design Quality Engineer to uphold robust design controls and regulatory compliance for the iovera product line in Bogotá. You will partner with R&D and cross-functional teams to ensure product development adheres to ISO 13485, 21 CFR 820, and EU MDR while supporting risk management, documentation, and continuous improvement throughout the product lifecycle.

This role emphasizes collaboration in sustaining engineering, design reviews, data analysis, and quality

Qualifications

Bachelor's degree in engineering or higher.
1–2 years in design, sustaining engineering, or medical device quality engineering.
Strong knowledge of Design Controls and Risk Management.

Responsibilities

Collaborate with R&D and cross-functional teams to support design control requirements.
Support design verification and validation, risk management, and design reviews to ensure safety and regulatory compliance.
Review engineering design changes and provide quality input for documentation, traceability, and risk assessment.
Assist in continuous improvement of design control processes, templates, and procedures to align with regulatory expectations.
Support sustaining engineering projects, providing quality support for compliance and product improvements.
Assist in complaint handling by reviewing data and contributing to root cause analysis.