Warsaw, Warsaw, Poland
39 days ago
Quality & Regulatory Affairs Specialist

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


This 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 Impact

 

Maintain 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 Background


Education:

Degree in business or engineering or professional experience in a similar position


Professional experience:

Experience in procedure writingKnowledge of business processes in a regulated environment


Special expertise:

Familiar with a variety of office software packages including MS Word, Power Point, Visio, Excel. Preferably 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 MDSAP


Languages:

Good command of English


Personal skills requirements:

Ability 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 management

EOE/M/F/Vet/Disability

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