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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 focused on orthopedic medical devices for the foot and ankle, is hiring an Associate Manager of Quality-Production. This position will be primarily onsite at our Englewood, Colorado headquarters with flexibility for remote work when necessary. The Associate Manager of Quality-Production is responsible for ensuring the daily compliance of P28’s quality management system within the quality team, including compliance to regulations and standards such as 21 CFR 820 and ISO 13485:2016. This role has a focus on production aspects of quality including: receiving inspection, process validation, software validation, measurement systems analysis, calibration, and preventative maintenance. This position is also responsible for the management of people within this team.

How You'll Create Impact

• Supports the execution of the company Quality System including all requirements as identified in 21 CFR 820 and ISO 13485; 2016
• Lead employees to meet the departmental and organizational expectations for productivity, quality, continuous improvement and goal accomplishment.

a. Coach, mentor and develop staff, including recruitment and onboarding, performance
- Responsible for ensuring execution of all required Software Validations, Process Validations, and Equipment Qualifications which affect the QMS or product quality
- Ensure calibration compliance of all gaging affecting product quality is maintained
- Responsible for executing Measurement Systems Analysis (MSA) including Gage Repeatability and Reproducibility (GRR) for all existing and proposed measurement methods
- Oversee monitoring and responding to temperature excursions for business-critical ultra-low temperature freezers, including outside of business hours if an emergency occurs.
- Ensure proper execution and documentation of required preventative maintenance activities for all equipment affecting product quality
- Aid in execution of assessment and dispositioning of field returned product
- Support receiving inspection activities, including identification and execution of continuous improvement projects to support quality lab and drive efficiency
- Assist in the proper identification of NCRs and appropriate actions with assistance from other team members
- Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices
- Other duties as assigned

Your Background

• Bachelor’s degree in engineering or technical discipline and 5 years of related experience
• Demonstrated ability to lead and manage technical teams, with experience managing direct reports preferred
• Knowledge and experience with measuring equipment and methodologies
• Ability to read and understand part drawings/GD&T
• Expertise with 21 CFR 820/ISO13485, and other government/ISO standards
• Strong interpersonal and communication skills and the ability to apply these skills when dealing with all levels of the organization
• Solid computer aptitude, including proficiency with Microsoft Office suite
• Superior organizational skills, attention to detail and ability to prioritize and manage multiple tasks and competing deadlines.
• Knowledge of Titanium, Stainless Steel, and Polymer machining is a plus.

Travel Expectations

Less than 10% of overnight travel; potential for either domestic or international travel.

Compensation Data

Salary: $90,000 - $120,000 USD annually depending on skills and experience

EOE