Associate Quality Engineer-Design

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
• 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.
• 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)
• Travel Expectations
• Less than 10% overnight travel.
• Compensation Data

•

Salary:

$50,000 - $70,000 based on skills and experience EOE