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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.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging.

What You Can Expect

Paragon 28, A Zimmer Biomet company, is hiring an Associate Quality Design Engineer. The Associate Quality Engineer - Design is a quality engineering position that has emphasis on developing and maintaining Paragon 28’s quality system and related quality activities specifically relating to product development, manufacturing, and supply chain of Paragon 28 products. This is an onsite position located at our headquarters in Englewood, Colorado.

How You'll Create Impact

+ 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

Your Background

• 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)

Work Environment

This job operates in an office and warehouse environment. This role routinely uses standard office equipment such as computers, phones and copy machines.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to communicate with individuals internal and external to the organization. The employee is required to have close visual acuity to perform activities such as inspecting small parts, viewing computer monitors, and reviewing reports. The employee frequently is required to move about the facility. The employee may be required to lift up-to 15 lbs. by themselves.

Position Type/Expected Hours of Work

This is a full-time position with typical business hours. It may reasonably require additional hours during the week and weekend; specific requirements will be determined with Manager.

Travel Expectations

Less than 10% overnight travel.

Compensation Data

Salary: $58,000 - $73,000 USD Annually based on skills and experience

EOE