Quality Engineer II – Medical Devices

About the role

Zimmer Biomet, a global medical technology company, is hiring a Quality Engineer II in Bogotá. The engineer assures that products conform to established requirements and standards through audit, inspection and test activities, and works with internal departments, suppliers and external experts to implement Zimmer Biomet's quality goals.

Key responsibilities

• Formulate procedures, specifications and standards for Zimmer products and processes.
• Review technical drawings, dimensions and tolerances to confirm product conformity.
• Develop and implement corrective and preventative action plans, and collect and analyze data for gauge and product evaluation.
• Identify the personnel, gauges, procedures and materials needed for new products, and ensure suppliers have the information and facilities to deliver quality products.
• Plan process and equipment validations (IQ/OQ/PQ).

Required profile

• Bachelor's degree in engineering or an alternative Bachelor's degree (Biomedical, Mechanical or other engineering also considered).
• At least 1 year of relevant work experience in manufacturing.
• Certified Quality Engineer (CQE) and experience in the medical device industry, especially orthopedics, in a 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 13485/21 CFR 820, CQE or similar certification, and experience with measuring equipment.

Required skills

• Microsoft Office Suite.
• Blueprint reading and geometric dimensioning and tolerancing.
• Understanding of QSR/ISO regulations, design assurance, FMEA and product testing methods.
• Use of optical comparators and CMMs.

What we offer

• Development opportunities and employee resource groups.
• A flexible working environment and location-specific competitive total rewards.
• Wellness incentives and a culture of recognition and performance awards.

Travel is expected 20% of the time; the role is hybrid with 4 days per month on site in Bogotá, Monday to Friday, 8:00am to 5:00pm.