Associate Quality Engineer - Design

Zimmer Biomet seeks an Associate Quality Engineer for its Paragon 28 subsidiary in Colorado to support medical device development and manufacturing. The role involves quality systems oversight, regulatory compliance, and cross-functional collaboration to ensure product excellence and patient safety.

Responsibilities

• Provide quality engineering support to project teams during product and process development
• Work with manufacturing personnel to establish quality metrics, sampling plans, and inspection methods
• Participate in non-conformance investigations and corrective/preventive action processes
• Support design control compliance with FDA QSR, European MDD/MDR, and ISO standards
• Assist in supplier qualification and verification/validation protocol execution

Requirements

• Bachelor's degree in engineering or technical discipline
• Familiarity with 21 CFR 820 and ISO 13485:2016 standards
• Technical writing skills for quality management systems and procedures
• Knowledge of geometric dimensioning and tolerancing (GD&T)
• Competent computer skills including MS Office Suite
• Medical device design controls experience preferred
• Machining methodologies knowledge preferred, particularly titanium and stainless steel

Compensation: $50,000 - $70,000 USD annually