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 ExpectThis position’s 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 ImpactMaintain the Quality Management SystemReview and approve processes and their training scopeReview and approve change requestsMaintain procedures and work instructionsSupport the development of electronic workflows and their testingCoach process owners in process improvement and process creationMonitor training effectiveness and completion rateCoordination of training needsArchiving of documents (Drawings, Change projects, Design Transfer, etc.)Assisting in CAPAYour BackgroundEducationDegree in business or engineering or professional experience in a similar positionProfessional ExperienceExperience in procedure writingKnowledge of business processes in a regulated environmentSpecial ExpertiseFamiliar with a variety of office software packages including MS Word, Power Point, Visio, ExcelPreferably knowledge of applicable ISO Standards in particular ISO13485, ISO 9001, ISO14971, the European Medical Device Regulation (MDR) 2017/745, other relevant European directives and general knowledge of US Quality System Regulations (21 CFR 820) and MDSAPLanguagesGood command (equivalent to CEFR level B2) in English both verbal and writtenWhat Makes You Stand OutPersonal Skills RequirementsAbility to work and think independentlyManaging projects and processesCross boundary teamworkStrong customer focusGood interpersonal skillsGood problem-solving ability and analytical skills, strong sense of initiative, follow-through and attention to detailMust be able to work with all levels of employees, including hourly production employees through senior managementTravel ExpectationsLess than 5%EOE/M/F/Vet/Disability

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Regulatory Compliance Technician