Design Quality Engineer (Bogotá)

Design Quality Engineer (Bogotá)

07 oct
|
Zimmer Biomet
|
Bogotá

07 oct

Zimmer Biomet

Bogotá

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a adaptable working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

What You Can Expect The Design Quality Engineer will support robust and compliant design control practices across new product development and sustaining engineering activities for the iovera product line. This role serves as a quality representative within cross-functional teams, supporting compliance with regulatory requirements (e.g., 21 CFR 820, ISO 13485, EU MDR) and internal quality standards.

The Design Quality

Engineer will support design changes, risk management activities, quality documentation, complaint investigations, and continuous improvement throughout the product lifecycle.

How You'll Create Impact

- 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.

What Makes You Stand Out
- Working knowledge of ISO 13485, 21 CFR 820, EU MDR
- Experience with Design Controls and risk management
- Statistical knowledge and understanding of measurement uncertainty

Your Background
- BS Degree or higher in engineering field required (e.g., Electrical, Systems, Mechanical engineering)
- Experience with design, sustaining engineering, or medical device quality engineering required
- Minimum 3 years’ experience in design, sustaining engineering, or medical device quality engineering required

Travel Expectations
- Occasional travel may be required to support product development activities, supplier visits, or audits.
- Le animamos a informarnos si tiene alguna discapacidad. Esta información será tratada de acuerdo con nuestro Aviso de Privacidad y las políticas locales de Zimmer Biomet para el procesamiento de datos personales con fines de reclutamiento. Garantizamos la confidencialidad y privacidad de esta información.

EOE/M/F/Vet/Disability

📌 Design Quality Engineer (Bogotá)
🏢 Zimmer Biomet
📍 Bogotá

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