Director (m/f) Risk Management

61348 Bad Homburg
09.01.2018

Daten dieser Anzeige

Job-ID: 006956627
Director (m/f) Risk Management

Fresenius Medical Care Deutschland GmbH

Germany

https://jobdb.softgarden.de/jobdb/public/jobposting/applyonline/click?jp=1635534

Develop and implement a Risk Management Program which manages product risk according to ISO14971, and regulatory compliance risk by implementation of a risk based approach throughout the Consolidated Quality Management System (CQMS), according to ISO 13485 Provide technical expertise overseeing the Risk Management Program for our regions EMEA, LA, AP including when and how to develop design, process, and user FMEA's in collaboration with Risk Management Process Owners Develop and maintain Risk Management files according to ISO 14971 Ensure timely review of post-marketing safety reports. Analyze the follow up requests to produce important MI (medical information) for assessments and evaluations and update the Risk Management files accordingly Coordinate production reporting in a timely manner so that it can be given to post-marketing with accurate information and used for surveillance and clinical trials, as applicable Continually enhance and develop skills in the multidisciplinary safety management team. Lead and train EMEA, LA, AP personnel on developing, updating, and approving the Risk Management files Work with Global R&D and Sustaining Centers on the development and incorporation of Risk Management during all design phases for new and/ or product changes and/ or enhancements Establish Compliant Reporting risk management system to help facilitate timely, accurate and sustained decision making to assure appropriate complaint outcomes Demonstrate knowledge of standards, guidance, and regulations which adhere to regulatory authorities

  / CAREER WITH A PURPOSE / Fresenius Medical Care - Creating a future worth living. For patients. Worldwide. Every day. More than four decades of experience in dialysis, innovative research, the global leader in dialysis services and products - that is Fresenius Medical Care. freseniusmedicalcare.com Director (m/f) Risk Management As Director Risk Management you will take the leading role in developing, implementing and maintaining the Risk Management Program within our international Consolidated Quality Management System for our regions EMEA, LA, AP within our business area Global Manufacturing & Quality (GMQ). More As Director Risk Management you will take the leading role in developing, implementing and maintaining the Risk Management Program within our international Consolidated Quality Management System for our regions EMEA, LA, AP within our business area Global Manufacturing & Quality (GMQ). Your assignments Develop and implement a Risk Management Program which manages product risk according to ISO14971, and regulatory compliance risk by implementation of a risk based approach throughout the Consolidated Quality Management System (CQMS), according to ISO 13485 Provide technical expertise overseeing the Risk Management Program for our regions EMEA, LA, AP including when and how to develop design, process, and user FMEA’s in collaboration with Risk Management Process Owners Develop and maintain Risk Management files according to ISO 14971 Ensure timely review of post-marketing safety reports. Analyze the follow up requests to produce important MI (medical information) for assessments and evaluations and update the Risk Management files accordingly Coordinate production reporting in a timely manner so that it can be given to post-marketing with accurate information and used for surveillance and clinical trials, as applicable Continually enhance and develop skills in the multidisciplinary safety management team. Lead and train EMEA, LA, AP personnel on developing, updating, and approving the Risk Management files Work with Global R&D and Sustaining Centers on the development and incorporation of Risk Management during all design phases for new and/ or product changes and/ or enhancements Establish Compliant Reporting risk management system to help facilitate timely, accurate and sustained decision making to assure appropriate complaint outcomes Demonstrate knowledge of standards, guidance, and regulations which adhere to regulatory authorities Your profile Successfully completed B.S. or M.S. in Mechanical-/ Bio-Medical Engineering or similar required 15 years + professional experience in Quality Engineering in the Medical Device Manufacturing Industry and/ or the Pharmaceutical industry Certified Quality Engineer and/ or Black belt preferred Previous experience in implementing Risk Management in accordance to ICH Q9 Guidance on Risk Management (or other applicable regulations or standards) Ability to work collaboratively, with good inter-personal and communication skills, and political awareness Knowledge of, and experience working with, international professional organizations, with awareness of worldwide regulatory and quality systems preferred Apply now Send via email Print this page At a glance Career level: Professional Experienced Job category: Medical Technology Working condition: Permanent contract / Full-time Business segment: Fresenius Medical Care Location: Bad Homburg / Hessen Closing date for applications: none - we look forward to your application Apply now Send via email Print this page Your contact Konstantin von Palm Fresenius Medical Care Deutschland GmbH Bad Homburg Ref. number: 25531 About Fresenius Career with a purpose: Over 250,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story. career.fresenius.com fresenius.com   One of Fresenius' strengths: our corporate culture for “entrepreneurs in an enterprise” where you can quickly take on responsibility. More reasons   The benefits we offer: Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs. More benefits Your contact Konstantin von Palm Fresenius Medical Care Deutschland GmbH Bad Homburg Ref. number: 25531 career.fmc-ag.com Career level: Professional Experienced Job category: Medical Technology Working condition: Permanent contract / Full-time Business segment: Fresenius Medical Care Location: Bad Homburg / Hessen Closing date for applications: none - we look forward to your application About Fresenius Over 250,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story. career.fresenius.com fresenius.com One of Fresenius' strengths: our corporate culture for “entrepreneurs in an enterprise” where you can quickly take on responsibility. More reasons The benefits we offer: Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs. More benefits

Unternehmensführung/ Management

Technische Berufe/ Fertigung/ Produktion

Ingenieurwesen

Projekt- und Produktmanagement/ Qualitätsmanagement

Pharma, Chemie, Med.-/ Biotechnologie

Medizintechnik/ Optik

Gesundheits-/ Sozialwesen/ Medizin

Bereichs-/ Abteilungs-/ Gruppenleitung

Angestellter/ Fachkraft

Vollzeit

61348 Bad Homburg