Director (m/f/d) Global Product Risk Management

61348 Bad Homburg
08.08.2019

Daten dieser Anzeige

Job-ID: 010930817
Director (m/f/d) Global Product Risk Management

Fresenius Medical Care Deutschland GmbH

Germany

https://karriere.fresenius.de/de/job_application/4627049/apply

Develop, implement, and oversee a Global Risk Management Program which manages «product risk» according to ISO14971, Product Cybersecurity Risk according to regional standards and «regulatory compliance risk» by implementation of a «risk based approach» throughout the Product Quality Management System, according to ISO 13485 Develop and expand the Global Risk Management Program scope to cover the complete product life cycle from pre-market to post-market Provide deep Risk Management subject matter expertise with a proven ability to communicate and instruct how to execute throughout the complete product lifecycle Develop an audit and inspection program that ensures Risk Management Files are developed and maintained according to procedures and relevant market standards Develop a leadership forum for Risk Management that encompasses Medical, R&D, Operations and Quality Leadership that champions the discipline of Risk Management as a Fresenius norm Implement a balanced scorecard/ metrics approach to raising product global risk management performance Collaborate with Executive Management to maintain a compliant and effective Risk Management and Medical Device cybersecurity system and organization that meets the needs of the business Develop risk management education and skill set development programs that continually enhance and develop skills in the multidisciplinary safety management team Develops strategies to ensure Risk Management element is robust, enhances compliance, meets Regulatory Body and business commitments, and realizes measurable gains in the reduction of risk to patients and increase in customer/ user satisfaction

  / 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/d) Global Product Risk Management As Director (m/f/d) Global Product Risk Management you will take the leading role in developing, implementing and maintaining the Risk Management Program in the Global Product Quality Management System within our business area Global Manufacturing, Quality & Supply. More As Director (m/f/d) Global Product Risk Management you will take the leading role in developing, implementing and maintaining the Risk Management Program in the Global Product Quality Management System within our business area Global Manufacturing, Quality & Supply. Your assignments Develop, implement, and oversee a Global Risk Management Program which manages «product risk» according to ISO14971, Product Cybersecurity Risk according to regional standards and «regulatory compliance risk» by implementation of a «risk based approach» throughout the Product Quality Management System, according to ISO 13485 Develop and expand the Global Risk Management Program scope to cover the complete product life cycle from pre-market to post-market Provide deep Risk Management subject matter expertise with a proven ability to communicate and instruct how to execute throughout the complete product lifecycle Develop an audit and inspection program that ensures Risk Management Files are developed and maintained according to procedures and relevant market standards Develop a leadership forum for Risk Management that encompasses Medical, R&D, Operations and Quality Leadership that champions the discipline of Risk Management as a Fresenius norm Implement a balanced scorecard/ metrics approach to raising product global risk management performance Collaborate with Executive Management to maintain a compliant and effective Risk Management and Medical Device cybersecurity system and organization that meets the needs of the business Develop risk management education and skill set development programs that continually enhance and develop skills in the multidisciplinary safety management team Develops strategies to ensure Risk Management element is robust, enhances compliance, meets Regulatory Body and business commitments, and realizes measurable gains in the reduction of risk to patients and increase in customer/ user satisfaction Your profile Degree in Engineering (Mechanical, Bio-Medical, Systems Engineering) or similar required 10 years minimum in Quality Engineering in the Medical Device Industry and ideally additionally in Pharmaceutical industry Expert knowledge of ISO13485 and ISO14971 Standards and their application in global markets Experienced in leading multiple and complex projects and initiatives as well as interdisciplinary teams Robust ability to make risk- based quality decisions to ensure patient needs are met Strong ability to build consensus and confidence in decisions at critical junctures in a project, while also stepping up to conflicts, hammering out agreements and settling disputes quickly and equitably Strong interpersonal skills with the ability to communicate with all levels of management through diplomacy and tact Flexibility and willingness to travel Apply now Send via email Print this page At a glance Career level: Professional Experienced Job category: Other, Medical Technology, Quality Management / Environment 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 Julia Probst Fresenius Medical Care Deutschland GmbH Bad Homburg Ref. number: 34373 About Fresenius Career with a purpose: Over 270,000 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 Julia Probst Fresenius Medical Care Deutschland GmbH Bad Homburg Ref. number: 34373 career.fmc-ag.com Career level: Professional Experienced Job category: Other, Medical Technology, Quality Management / Environment 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 270,000 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

Technische Berufe/ Fertigung/ Produktion

Unternehmensführung/ Management

Pharma, Chemie, Med.-/ Biotechnologie

Ingenieurwesen

Projekt- und Produktmanagement/ Qualitätsmanagement

Medizintechnik/ Optik

Gesundheits-/ Sozialwesen/ Medizin

Bereichs-/ Abteilungs-/ Gruppenleitung

Angestellter/ Fachkraft

Vollzeit

61348 Bad Homburg