Design Quality Engineer - Medical Devices (Associate)

Zimmer Biomet; Englewood (CO); On-site; USD 50,000 - 70,000; Full time

Job summary

Paragon 28 (a Zimmer Biomet company) is seeking an Associate Quality Engineer - Design to join our Englewood, Colorado team. You will serve as a guardian of product quality and patient safety, contributing to the design controls, risk management, and supplier quality processes from early development through transfer to manufacturing.

You will collaborate with design and manufacturing, support quality metrics, audits, CAPA, and verification/validation activities, while applying ISO 13485, FDA

Qualifications

• 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).

Responsibilities

• 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

Skills

Quality engineering

Regulatory awareness

GD&T

Technical writing

Education

Bachelor’s in engineering

Tools

MS Office Suite

SAP

Job description

Paragon 28 (a Zimmer Biomet company) is seeking an Associate Quality Engineer - Design to join our Englewood, Colorado team. You will serve as a guardian of product quality and patient safety, contributing to the design controls, risk management, and supplier quality processes from early development through transfer to manufacturing.

You will collaborate with design and manufacturing, support quality metrics, audits, CAPA, and verification/validation activities, while applying ISO 13485, FDA