Vice President (m/f) Quality Assurance & Regulatory Compliance (Qualitätsmanager/in / Projektmanager/in Regulatory Affairs, Approbationsingenieur/in / Wirtschaftsingenieur/in)

Bensheim
05.10.2017

Daten dieser Anzeige

Job-ID: 1292764__1
Vice President (m/f) Quality Assurance & Regulatory Compliance (Qualitätsmanager/in / Projektmanager/in Regulatory Affairs, Approbationsingenieur/in / Wirtschaftsingenieur/in)
Manage the quality and regulatory responsibilities across the Strategic Business Units (SBUs)

Vice President (m/f) Quality Assurance and Regulatory Compliance (Qualitätsmanager/​ in bzw. Projektmanager/in Regulatory Affairs, Approbationsingenieur/in oder Wirtschaftsingenieur/in) Logo Committed to excellence, we are currently looking to recruit a highly motivated leader (Quality Manager, Manager Regulatory Affairs, Approbation Engineer or Business Engineer) to join our Business Team, located in Bensheim (Germany), as Vice President (m/f) Quality Assurance and Regulatory Compliance Your Accountabilities as Vice President (m/f) Quality Assurance and Regulatory Compliance As Vice President Quality Assurance and Regulatory Compliance you will manage the quality and regulatory responsibilities across the Strategic Business Units (SBUs) of Imaging, CAD/CAM, Treatment Centers and Instruments and their related locations in Bensheim, FONA Milano, FONA Guangzhou, New York, Risskow Denmark. You will upgrade and implement the quality systems to comply with the applicable regulations of FDA, ISO 13485:2016, MDSAP as well as MDR, JPAL and other country specific requirements. You will focus on the Quality Management System for the above mentioned entities including Complaint System, CAPA System, Internal Audits, Management Responsibility, Design Control, Process Validation etc. and act as the Quality Management Representative and the responsible person under German law and manage the relationship with FDA, competent authorities, notified bodies and all other regulatory authorities and develop and manage a fiscal budget. Reporting to the position will be the Heads of Quality for each site and SBU as well as the Regulatory/Approbation Engineering. Your Accountabilities as Vice President Quality Assurance and Regulatory Compliance (m/f) in detail * Implement and maintain a system and process for: * Inspection and testing of raw materials, in-process materials, finished products and appropriate dispositions. * Calibration controls and document control activities. * Identification of and compliance with applicable external quality system standards. * Product and process change control activities. * CAPA and supplier management. * Record retention at SBU, product portfolio and plant level. * Labeling review and approval Establish and maintain a quality system to attain CE certification for products at an SBU and plant level. At the same time, ensure quality system compliance in accordance with FDA's requirements at the site level and at SBU level. Act as a management representative. Compliance with corporate policies and procedures at SBU as well as at site level. Performance of management oversight activities at SBU, product portfolio and plant level, including appropriate review of quality data, quality policy, quality objectives and resources. Compliance with the internal audit program at SBU and at site level, including scheduling, performance, follow-up activities and reporting. Compliance with process validation requirements. Compliance with design control requirements in accordance with internal, FDA's QSR and MDD requirements. Compliance with complaint management requirements including initiation, assessment of reportability requirements for Canada and EU, recommendation for reportability for US, investigations, and closure. Manage all external audits at SBU as well as at plants. Prepare appropriate responses to any audit findings. Integrate a harmonized quality management system between the SBUs and Central Quality at the Bensheim site. The Requirements as Vice President (m/f) Quality Assurance and Regulatory Compliance (Quality Manager, Manager Regulatory Affairs, Approbation Engineer or Business Engineer) * University degree in engineering or scientific discipline. * Significant years of quality management experience in a medical device environment and proven leadership skills. * Experience in managing multi-site and multi-culture situations at a senior level. * Exceptional teamwork, presentation,communication and relationship skills, gained in an international business environment. * Excellent decision making and analytical skills. * Fluent proficiency in spoken and written English and German. * Willingness to travel (i.e. EMEA Region). The ideal candidate is driven for results and works effectively to build relationships to ensure all parties are satisfied. What can you expect from us? As a brand champion within the dental equipment industry, Dentsply Sirona has been generating significant growth in recent years, particularly in the international business arena. We are able to offer you a challenging and thoroughly absorbing role within our company, together with outstanding prospects for personal development. In addition to receiving an attractive remuneration package that is commensurate with performance, you can look forward to working with professional, results-driven colleagues who recognise the merits of a cordial, team-based environment. Interested in joining our team? If your credentials match our profile, we look forward to hearing from you. Please send us your full application, quoting Ref. 17-994 and specifying your salary requirements as well as your earliest start date. Please upload your application directly to our recruitment platform. Applications by e-mail are also welcome. Please Apply Here Dentsply Sirona, The Dental Solutions Company(TM) HR Management karriere@sirona.com About Dentsply Sirona Dentsply Sirona is the world's largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world-class brands. As The Dental Solutions Company(TM), Dentsply Sirona's products provide innovative, high-quality and effective solutions to advance patient care and deliver better, safer and faster dentistry. Dentsply Sirona's global headquarters is located in York, Pennsylvania, and the international headquarters is based in Salzburg, Austria. The company's shares are listed in the United States on NASDAQ under the symbol XRAY. Visit www.dentsplysirona.com for more information about Dentsply Sirona and its products. 360Grad Galerie von Dentsply Sirona blablabla

Ingenieurwesen

Medizintechnik/ Optik

Bereichs-/ Abteilungs-/ Gruppenleitung

Vollzeit

Bensheim