Design Quality Engineer I - Med Device

Zimmer Biomet; Bogotá ciudad; On-site; COP 60,000,000 - 90,000,000; Full time

Job summary

Zimmer Biomet seeks a Design Quality Engineer to drive design control compliance across new product development and sustaining engineering for the iovera line. You will serve as a quality representative on cross‑functional teams, supporting regulatory requirements and internal standards.

The role emphasizes design changes, risk management, documentation, and continuous improvement throughout the product lifecycle, with strong collaboration across R&D, Regulatory, Operations, and Quality

Qualifications

• BS degree or higher in engineering (Electrical, Systems, Mechanical, Bio medical)
• Experience with design, sustaining engineering, or medical device quality engineering
• Minimum 1-2 years’ experience in design, sustaining engineering, or medical device quality engineering
• Strong knowledge of Design Controls and Risk Management
• Advanced Excel skills; Advanced English communication

Responsibilities

• Collaborate with R&D and cross-functional teams to support design control requirements throughout product development and lifecycle management.
• Support design verification and validation, risk management, and design reviews to help ensure applicable safety, performance, and regulatory requirements are met.
• Review engineering design changes and provide quality input to ensure appropriate documentation, traceability, and risk assessment.
• Support continuous improvement of design control processes, templates, and procedures to align with regulatory expectations and business needs.
• Participate in sustaining engineering projects, providing quality support to maintain compliance and support product improvements.
• Support complaint handling by reviewing complaint data, participating in root cause analysis, and identifying design‑related trends or failure modes.
• Assist in preparing quality deliverables for regulatory submissions, including 510(k)s, technical documentation, and IDE‑related documentation.
• Support internal and external audits by preparing relevant design history and risk management documentation.
• Collaborate with Regulatory Affairs, Operations, Manufacturing, and Quality Assurance to support consistent approaches to design quality.
• Support quality metric tracking and management review inputs related to design control and product quality performance.
• Perform other quality‑related duties assigned by management, including but not limited to supporting CAPA investigations, nonconformance (NC) evaluations, data analysis, and continuous improvement initiatives.

Skills

Design Controls

Risk Management

Statistical Analysis

Measurement Uncertainty

Regulatory Knowledge

Excel

English Proficiency

Cross-functional Collaboration

Quality Assurance

Data Analysis

Education

Bachelor's in Engineering

Job description

Zimmer Biomet seeks a Design Quality Engineer to drive design control compliance across new product development and sustaining engineering for the iovera line. You will serve as a quality representative on cross‑functional teams, supporting regulatory requirements and internal standards.

The role emphasizes design changes, risk management, documentation, and continuous improvement throughout the product lifecycle, with strong collaboration across R&D, Regulatory, Operations, and Quality