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

 

As a Regulatory Compliance Engineer, your primary focus is to maintain and coordinate the quality management system to ensure compliance with internal and external requirements (corresponding regulations and standards) by supporting the change management, document and record management, training, audit, and management review processes. Internal customer focus is essential to successfully collaborate with all Zimmer Biomet departments.

How You'll Create Impact

 

The main objective is to maintain and optimize the Quality Management System:

Responsible for QMS compliance to all applicable regulations and standardsReview and approve processes and their training scopeReview and approve change requestsCreate and maintain new procedures and work instructionsSupport the development of electronic workflows and their testingCoach process owners in process improvement and process creationLead or assist quality planning, CAPA or other projectsMonitor training effectiveness and completion rate, deliver quality trainingsCoordination of training needsAssist internal, product and external auditsSupport Management Review MeetingsArchive documents (Drawings, Change projects, Design Transfer, etc.)What Makes You Stand Out

 

Good interpersonal skillsCross boundary teamworkStrong customer focusGood problem-solving ability and analytical skills, strong sense of initiative, follow-through and attention to detailAbility to work and think independentlyAbility to effectively prioritize and execute tasks in a high-pressure environment is crucialAbility to work with all levels of employees, including hourly production employees through senior managementAbility to train personnelYour Background

 

You hold a degree in business or engineering (or professional experience in a similar position) and, ideally, a certification as lead auditor. 

 

You have a proven track record in the medical devices industry and have developed a good knowledge of applicable ISO standards (ISO13485, ISO9001, ISO14971, European Medical Device Regulation (MDR) 2017/745, other relevant European directives, US Quality System Regulations (21 CFR 820) and MDSAP).

 

In addition, you have experience in procedure writing and you are familiar with a variety of office software packages including MS Word, Power Point, Visio, Excel,databases and SAP.

 

English fluency is required, good command of German is preferred.

EOE/M/F/Vet/Disability