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Risk Management & PMS Senior Engineer 100% m/f/d

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Offered by:

Zimmer GmbH

Medical
Winterthur

Your main responsibilities: 

  • Participate as subject matter expert in audits by FDA, Notified Bodies, internal audit program, etc.
  • Leads projects regarding Risk Management initiatives (e.g., process improvements, introduction of tools)
  • Leads and coordinates Risk Management activities and creation of Risk Management Files
  • Ensures that requirements for Risk Management and process transfer are applied
  • Leads and coordinates CAPA’s / CAPA tasks and ensures that CAPA process requirements are applied.
  • Supports other functions to perform and document CAPA’s and CAPA tasks (e.g. problem statement, root cause analysis, corrections, corrective and preventive actions)
  • Supports and/or prepares trending reports for Management Review and Trending Review
  • Acts as PMS responsible/ Subject Matter Expert (SME) to “Reporting /Lot Blocking” and supports in the specific segment as agreed with the line manager internal and external audits as Subject Matter Expert (SME)
  • Performs training for the PMS group and collaborating groups/departments at Zimmer and ensures process compliance with changing corporate and international requirements
  • Act as a coordinating point related to HCP (Health Care Professional)
  • Monitors the effectiveness of CAPA-System (generates and presents CAPA metrics)
  • Maintains and improves processes regarding CAPA, Risk Management, Product Hold and Health Hazard Evaluation
  • Supports key stakeholders and performs training regarding Risk Management and CAPA

 Your Qualifications and Experience: 

  • Technical degree or equivalent (sound technical background)
  • At least 4 years of practical experience in the medical device industry or other regulated industry
  • Kledge of applicable Regulations and Standards, in particular ISO13485, ISO14971, the Medical Device
  • Directive 93/42/EEC and Medical Device Regulation (MDR 2017/745), US Quality System Regulations (QSR)
  • Solid background in general quality assurance activities, e.g. Risk Management, CAPA
  • Effective use of office software packages including MS Word, Power Point, Visio, Excel, SAP and MS Project
  • od background in project management
  • K How of regulatory requirements for key quality systems elements and its interdependency within the quality system
  • Experienced and able to work both independently and in a team-oriented, collaborative environment.
  • Can conform to shifting priorities, demands and timelines
  • Must be able to learn, understand, and apply new technologies
  • Ability to effectively prioritize and execute tasks in a high-pressure environment is crucial
  • Excellent command in English and German both verbal and written


If you seize this opportunity, you will be able to develop your international experience and be a part of a great and truly global team.Zimmer offers a wide range of challenging career advancement opportunities and a dynamic work environment. We look forward to receiving your complete application through the following link. For this position, we accept direct applications only. Zimmer Switzerland Manufacturing GmbH Kübra DurHuman Resources GeneralistSulzerallee 8                                      8404 Winterthur                                                                                                                               

www.zimmerbiomet.com