Senior Manager Design Quality (m/f/d)

36251 Bad Hersfeld
18.09.2020

Daten dieser Anzeige

Job-ID: 016828757
Senior Manager Design Quality (m/f/d)

Fresenius Kabi Deutschland GmbH

Germany

https://jobdb.softgarden.de/jobdb/public/jobposting/applyonline/click?jp=7664045

Ensuring that structures, systems and processes needed for the quality management system are established, documented, implemented, maintained and improved following a risk based approach. Ensuring processes and products are appropriate, adequate, effective and in compli-ance with applicable quality standards and regulatory requirements (ISO9001, ISO 13485, Medical Devices Directive 93/42/EEC, European Medical Device Directive, the Quality System Regulation 21 CFR 820/803/806, the Canadian Medical Device Regula-tion, Japan MHLW Ordinance No. 169, the Taiwan Pharmaceutical Affairs Act, Brazilian Good Manufacturing Practices, Australian Therapeutic Goods and others as applicable). Support Quality Systems by driving regulatory compliance and continuous improvement activities in accordance with applicable regulations and business goals and objectives. Ensure safe and effective medical devices are designed in compliance with the regula-tory requirements and QMS and support generation of technical files. Ensure that design projects comply with regulatory requirements and internal quality guidelines. Participate actively in and leading of all stages of design development, V&V testing and design control activities, ensuring quality assurance considerations and requirements are met. Perform detailed quality reviews, approve project results, and release new develop-ments, product changes and deliverables. Define quality control standards. Lead and support interdisciplinary teams (R&D, Production, Medical Affairs, Regulatory Affairs) in implementation of Risk. Creation and assurance of documentation in accordance with state-of-the-art regula-tions and standards. Moderate and drive risk assessments; conduct FMEAs. Generate and maintain the risk management files. Contribute to risk management activities: Identify sources of risk such as ergonomics, use error and risks associated with product characteristics. Support post-market surveillance activities. Contribute to and support Human Factors Engineering activities.

  / CAREER WITH A PURPOSE / Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used to help care for critically and chronically ill patients. Senior Manager Design Quality (m/f/d) For the location in Bad Hersfeld we are looking for you as a Senior Manager Design Quality. The Fresenius Kabi Business Unit for Application Devices Disposables is located here and is including next to global product management the Research & Development department as well as Regulatory Affairs. Moreover, operational functions like Quality Management, Supply Chain Management, Controlling and Product Partnering are stationed at Bad Hersfeld too. More For the location in Bad Hersfeld we are looking for you as a Senior Manager Design Quality. The Fresenius Kabi Business Unit for Application Devices Disposables is located here and is including next to global product management the Research & Development department as well as Regulatory Affairs. Moreover, operational functions like Quality Management, Supply Chain Management, Controlling and Product Partnering are stationed at Bad Hersfeld too. Your assignments Ensuring that structures, systems and processes needed for the quality management system are established, documented, implemented, maintained and improved following a risk based approach. Ensuring processes and products are appropriate, adequate, effective and in compli-ance with applicable quality standards and regulatory requirements (ISO9001, ISO 13485, Medical Devices Directive 93/42/EEC, European Medical Device Directive, the Quality System Regulation 21 CFR 820/803/806, the Canadian Medical Device Regula-tion, Japan MHLW Ordinance No. 169, the Taiwan Pharmaceutical Affairs Act, Brazilian Good Manufacturing Practices, Australian Therapeutic Goods and others as applicable). Support Quality Systems by driving regulatory compliance and continuous improvement activities in accordance with applicable regulations and business goals and objectives. Ensure safe and effective medical devices are designed in compliance with the regula-tory requirements and QMS and support generation of technical files. Ensure that design projects comply with regulatory requirements and internal quality guidelines. Participate actively in and leading of all stages of design development, V&V testing and design control activities, ensuring quality assurance considerations and requirements are met. Perform detailed quality reviews, approve project results, and release new develop-ments, product changes and deliverables. Define quality control standards. Lead and support interdisciplinary teams (R&D, Production, Medical Affairs, Regulatory Affairs) in implementation of Risk. Creation and assurance of documentation in accordance with state-of-the-art regula-tions and standards. Moderate and drive risk assessments; conduct FMEAs. Generate and maintain the risk management files. Contribute to risk management activities: Identify sources of risk such as ergonomics, use error and risks associated with product characteristics. Support post-market surveillance activities. Contribute to and support Human Factors Engineering activities. Your profile Higher professional technical education (e.g. University). Thorough knowledge of FDA Quality System requirements, ISO 13485 and 9001 (Quali-ty System) requirements, ISO 14971 (Risk Management) requirements ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements, Knowledge of Good ManufacturingPractices (GMP) and applicable Quality System Standards.  Min 3 years QA experience. Min 3 years experience with medical devices. Fluently English (speaking & writing).  Proficient in MS Office software. Professional, responsible, reliable, enthusiastic, proactive person with a hands on mentality and who has a seniority on QA-topics and project leadership. Able to work in cross functional teams. Ability to effectively lead projects/ activities; design and drive change, make decisions. Technical and business competencies that drive results and continuous improvement. Excellent analytical, problem solving, and troubleshooting skills. Strong organizational, interpersonal and communication skills (capable to communicate at different levels (with top management, market units, RA experts, local employees). Intercultural competence (cooperates closely with others, exchanges and conveys «best practice»). Teamwork oriented. Zusätzliche Infos Are you ready for this new challenge? Then we look forward to your application. Apply now Send via email Print this page At a glance Career level: Professional Experienced Job category: Quality Management / Environment Working condition: Permanent / Full-time Business segment: Fresenius Kabi Location: Bad Hersfeld / Hessen Closing date for applications: none - we look forward to your application Apply now Send via email Print this page Your contact Paola Altmüller Fresenius Kabi Deutschland GmbH Bad Hersfeld Ref. number: 40278 About Fresenius Career with a purpose: Over 290,000 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 Paola Altmüller Fresenius Kabi Deutschland GmbH Bad Hersfeld Ref. number: 40278 fresenius-kabi.com Career level: Professional Experienced Job category: Quality Management / Environment Working condition: Permanent / Full-time Business segment: Fresenius Kabi Location: Bad Hersfeld / Hessen Closing date for applications: none - we look forward to your application About Fresenius Over 290,000 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

Pharma, Chemie, Med.-/ Biotechnologie

Projekt- und Produktmanagement/ Qualitätsmanagement

Technische Berufe/ Fertigung/ Produktion

Ingenieurwesen

Medizintechnik/ Optik

Angestellter/ Fachkraft

Vollzeit

36251 Bad Hersfeld