Associate Design Quality Engineer - Patient

Associate Quality Engineer – Design

Join Zimmer Biomet to support our fast‑moving R&D team in Englewood, Colorado. As an Associate Quality Engineer – Design, you’ll help shape the quality foundation behind every Paragon 28 product and contribute to quality systems across product development, manufacturing, and supply chain operations.

• Participate on project teams providing quality engineering support under the direction of senior design quality engineers and management in the development of new products and processes, supporting legacy released systems, and continuously improving company’s products.
• Support manufacturing (internal and external), work with production personnel and supervision to determine and monitor quality metrics, sample plans, and inspection methods.
• Participate in the non‑conforming product process to address and resolve issues and support corrective and preventive action investigations.
• Perform inspections and use typical equipment used in inspection.
• Assist project teams on compliance with design control requirements per FDA, European MDD/MDR, ISO 13485 and other applicable ISO/EN standards.
• Participate in risk management activities in compliance with ISO 14971 as expressed in the company’s Quality Management System.
• Assist in supplier qualification process; interface with suppliers to ensure product compliance to specification.
• Support the execution of verification & validation protocols, testing, and generation of test reports.
• Assist in Design Control and Transfer for release of new product development projects.
• Support the writing and reviewing of procedures, plans, protocols, and reports to ensure regulatory compliance.
• Accurately represent quality processes to third‑party auditors (FDA, ISO 13485, MDSAP, etc.).
• Other duties as assigned.

• Bachelor’s degree in engineering or technical discipline.
• Familiarity with 21 CFR 820, ISO 13485:2016 and other Government/ISO Standards.
• Familiarity with Medical Device Design Controls preferred.
• Technical writing skills that include Quality Management Systems (QMS) and procedures.
• Knowledge in Geometric Dimensioning and Tolerancing (GD&T).
• Knowledge in machining methodologies preferred (Titanium and stainless‑steel experience best); knowledge of hardness, passivation, surface treatments, cleaning techniques for communication with suppliers and engineers.
• Competent computer skills (MS Office Suite, SAP preferred).

Less than 10% overnight travel.

Salary: $58,000 – $73,000 USD annually depending on skills and experience.

Zimmer Biomet is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment.