Quality Engineer II

Zimmer Biomet; Bogotá; Hybrid; COP 42,000,000 - 70,000,000; Full time

Job summary

Zimmer Biomet in Bogotá is seeking a Quality Assurance professional to ensure products meet established requirements through audits, inspections, and testing. The role collaborates with multiple departments and suppliers to uphold quality goals and compliance.

Ranked for process validation experience (IQ/OQ/PQ) and a strong background in medical devices, you will contribute to continuous improvement, data analysis, and action plans while operating in a hybrid Bogotá setting with travel

Qualifications

• Bachelor’s degree in engineering or equivalent; CQE or similar certification preferred.
• Minimum 1 year of manufacturing experience in medical devices.
• Hands-on validation experience (IQ-OQ/PQ) required.

Responsibilities

• Audit, inspect, and test products to ensure conformance.
• Review technical drawings for accuracy and tolerance.
• Develop corrective and preventive action plans.
• Collect data for gauge and product evaluation.
• Coordinate with suppliers to ensure quality delivery.
• Plan and execute IQ/OQ/PQ validations.

Skills

Teamwork and collaboration

Effective communication

Deadline-oriented

Growth potential

Education

Bachelor’s degree in engineering (Biomedical/Mechanical acceptable)

CQE or similar certification

Tools

CMMs

Optical comparators

GD&T

Blueprint reading

FMEA

Job description

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 flexible 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

Responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. Interacts with many different functional departments, suppliers, and experts outside Zimmer Biomet to implement Zimmer Biomet Quality goals.

How You'll Create Impact

• Formulates procedures, specifications, and standards for Zimmer products and processes.
• Review techicnical drawings, dimensions and tolerance to confirm product conformity.
• Develops and implements corrective/preventative action plans.
• Collects and analyzes data for gauge and product evaluation.
• Identifies critical personnel, gauges, procedures, and materials needed for the completion of new products.
• Ensures that suppliers have necessary information and facilities to deliver quality products to Zimmer Biomet.
• Plan and ezcecute process and equipment validations (IQ/OP/PQ).

What Makes You Stand Out

• Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
• Ability to deliver, meet deadlines and have results orientation.
• Able to communicate both orally and in written form to multiple levels of the company.
• Demonstrates characteristics of high potential for future development opportunities.
• Microsoft Office Suite
• Proficient in blueprint reading and geometric dimensioning and tolerancing, thorough understanding of QSR/ISO regulations, design assurance, FMEA, and product testing methods, and are able to use optical comparators and CMMs.

Your Background

• B.S. in engineering or an alternative Bachelor’s degree (Biomedical, Mechanical or other Engineering also considered).
• Minimum 1 year of relevant work experience in manufacturing.
• Certified Quality Engineer (CQE) and Medical device, particularly Orthopedic industry, experience in manufacturing plant (medical devices, pharma, metalworking).
• Hands - on experience in process validation (IQ-OQ/PQ)

Nice To Have

• Experience in medical devices.
• Knowledge of ISO 13485/21CFR 820
• CQE or similar quality certification
• Experience with mesuring equiptment.

Travel Expectations

Travel: 20%

Hybrid role

4 days per motnh on site in Bogotá.

Schedule

Monday to friday. 8:00am - 5:00pm.

We encourage you to let us know if you have a disability, which will be handled in accordance with our Privacy Notice - Local Language Policies | Zimmer Biomet for processing your personal data for recruitment purposes. We guarantee the confidentiality and privacy of this information.

Privacy Notice - Local Language Policies | Zimmer Biomet

Please select your language for the Zimmer Biomet Privacy Notice.

EOE/M/F/Vet/Disability