Quality Engineer I

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
• Step into a role where precision meets purpose.

Paragon 28, a Zimmer Biomet company, is looking for a Quality Engineer I - Production to help us redefine foot and ankle care.

If you're passionate about orthopedic excellence and thrive in the technical details of quality systems, we want you on our team. You'll be at the heart of our production quality—owning everything from process and software validation to MSA and calibration. Why join us? +

Focus:

Specialization in lower extremity innovation. +

Impact:

Ensure daily compliance (ISO 13485 & 21 CFR 820) that directly affects patient outcomes. +

Growth:

Work within a dynamic team dedicated to maintaining the highest standards in the industry. Ready to make every step count? Apply today to join the P28 team located in Englewood, Colorado!

• How You'll Create Impact
• + Support execution of Quality Department KPI's + Author and execute required Software Validations, Process Validations, and Equipment Qualifications which affect the QMS or product quality + Author and execute Measurement Systems Analysis (MSA) including Gage Repeatability and Reproducibility (GRR) on existing and proposed measurement methods + Respond to temperature excursions for business-critical ultra-low temperature freezers, including outside of business hours if an emergency occurs.

+ Aid in proper execution and documentation of required preventative maintenance activities for all equipment affecting product quality + Aid in assessment and dispositioning of field returned product + Lead investigations into out of tolerance gaging response activities + 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 associated actions with assistance from other team members + Support execution of QMS functions including Issue Evaluation, CAPA, Product Hold, HHE, etc., as assigned. Ensure proper completion per associated timeliness KPIs.

Other duties as assigned

• Your Background
• + Bachelor's in Engineering or technical discipline and 2 years of related experience + Medical device experience preferred + Knowledge and experience with measuring equipment + Process Validation experience preferred + Experience reading and interpreting part drawings/GD&T and use of measuring equipment a plus + 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. + Technical writing skills that include Quality Management Systems (QMS) and procedures + Familiarity with 21 CFR 820/ISO13485 and other government/ISO standards + Strong computer skills (MS Word & Excel)

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

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Salary Range:

$62,000-$85,000 USD annually depending on skills and experience EOE