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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 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.

What You Can Expect

Manage the document control and learn management system and function; conduct compliance train under minimal supervision; maintain document control program and product release function to ensure compliance to domestic and international medical device regulations; manage the identification, implementation, and support of automated tools to support the quality management processes; manage projects related to the introduction and support of automated quality systems; ensure compliance of automated quality systems to the QSR, other applicable regulations/standards, and internal procedures, including but not limited to validation; maintain records of training documentation according to organizational and regulatory requirements; assure all departments have effective assigned training to ensure compliance with regulatory and job skill requirements; ensure that all applicable personnel are trained on new or revised internal procedures; pursue and monitor corrective and preventive actions for applicable processes; coordinate department in creation of device master records; coordinate the archival of device master records and device history records to demonstrate compliance to GMP, ISO, and MDD regulations; assist department efforts in audits, both internal and external, to demonstrate compliance with GMP, ISO, and MDD regulations; manage the change control program; assist implementation of quality improvement projects; and coordinate department efforts for annual archival of records to offsite storage facility.

How You'll Create Impact

What Makes You Stand Out

Must have 5 years of experience in job offered or related position.

Must have 3 years of experience in the following:

+ FDA regulated industry experience; and

+ total engineering project experience including leading CAPA process use DMAIC methodology.

Must have 2 years of experience with the following:

+ Apply statistical analysis for quality control/assurance and CAPA verification of effectiveness plan;

+ review and approve CAPA metrics and quality system records in a manner complaint with 21 CFR Part 820 & part 11 regulations and IS013485;

+ ISO quality systems auditing;

+ presenting to a non-technical audience;

+ provide training to a technical audience; and

+ lean manufacturing projects.

Your Background

+ Requires a Bachelor's in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, Pharmaceutical Sciences, or related field.

Travel Expectations

+ Role permits remote work throughout the U.S. Role requires up to 10% domestic travel.

+ 40 hours per week, Monday through Friday, 8:30 AM to 5:00 PM

Zimmer, Inc., 56 E Bell Drive, Warsaw, IN 46582

EOE/M/F/Vet/Disability