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Zimmer Biomet in Warsaw, IN is seeking a qualified Quality Engineer to support calibration, NCR, CAPA, and CAPA-like initiatives. You will follow GMP/SOPs, review procedures, and drive continuous improvement with data analysis and training delivery.
You will identify out-of-tolerance issues, participate in investigations, publish metric trend plans for calibration, and assist in revising procedural documentation to meet regulatory requirements. Some travel may be required.
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 talent 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 included, respected, empowered and recognised.
In this role you will work with the quality engineers supporting day to day operations, Non Conformance Reports-(NCRs), Out of Tolerance Gage Reports, Customer Complaints, Corrective and Preventive Action- (CAPA) development and implementation, Operational Procedures revisions and Continuous Improvement (CI) initiatives. You will have the chance to actively support and participate in special projects. A key part of this role will be the strict observance of company’s procedures, GMP’s, SOP’s and other internal and external requirements or regulations.
You will identify, report and seek corrections for calibration out of tolerance (OOT) incidents
You will be responsible for actively participating in investigations: Non Conformance Report (NCR), Out of Tolerance, and Customer Complaints
You will publish Metric Trending Plans for Calibration. Assist with Corrective and Preventive Action (CAPA) resolution
You will assists with revising Operational Procedures and Continuous Improvement (CI) initiatives
You will deliver trainings to other team members that will perform tasks related to the same area
You will execute validation protocols, gage repetitivity and reproducibility (R&R) testing, data analysis and completes the required reports
You have proficient technical writing abilities
You have broad knowledge of good documentation practices and good manufacturing processes
You have the ability to read and interpret blue prints and drawings
You are knowledgeable in the area of Geometric, Dimensioning & Tolerancing (GD&T)
It's an advatnage if you have ASQ Quality Technician Certification
You have high school diploma or GED
You have five years of relevant experience
You are computer literate: Microsoft Word, Excel and Power Point.
Less than 5%
Expected Compensation: $63,000–$79,000 base salary, plus performance bonuses
EOE/M/F/Vet/Disability