Associate Quality Engineer - Design

• Participate on project teams as a contributing member by providing quality engineering support under the direction of Sr. Design Quality Engineers & management in the development of new products and processes, supporting legacy released systems, and continuously improving company’s products.
• Provide support for the manufacturing areas (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. Support corrective and preventive action investigations to resolve the root cause of problems.
• Perform inspections and use typical equipment used in inspection.
• Assist project teams on compliance with design control requirements per FDA QSR, 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 3rd party auditors (FDA, ISO 13485, MDSAP, etc.)
• Other duties as assigned

• Bachelor’s in engineering or technical discipline
• Familiarity with 21 CFR 820 and 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 preferrable (Titanium and Stainless-Steel experience best), knowledge of hardness, passivation, surface treatments, cleaning techniques etc. for communication with Suppliers and Engineers.
• Competent computer skills (MS Office Suite, SAP Preferred)

Travel Expectations

Less than 10% overnight travel.

Salary Range: $50,000 - $70,000 USD Annually depending on skills and experience

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., Paragon 28 (a Zimmer Biomet company) is seeking an Associate Quality Engineer - Design to join our team in Englewood, Colorado . In this role, you will be a guardian of product excellence and patient safety. Rather than just checking boxes, you will play a hands-on role in developing and maintaining our quality systems from day one. You will sit at the vital intersection of innovation and execution-directly influencing product development, shaping manufacturing processes, and strengthening our supply chain to bring world-class products to life.