Senior Auditor

vor 2 Wochen

Leipzig, Deutschland Life Science People Vollzeit

Job Title: Qualified Medical Device Auditor


Location: Germany


About Us: I am supporting a leading Notified Body in the medical device industry, renowned for our commitment to quality and safety in the healthcare sector. They provide certification, testing, and auditing services to ensure that medical devices meet regulatory standards and contribute to patient safety.


Job Overview: They are seeking a highly qualified and experienced Medical Device Auditor to join their team in Germany. The ideal candidate will have a strong background in the medical device industry, exceptional auditing skills, and in-depth knowledge of regulatory standards. This role involves conducting thorough audits of medical device manufacturers to ensure compliance with relevant regulations and standards.


Key Responsibilities:


  • Conduct comprehensive audits of medical device manufacturers to assess compliance with European and international regulations (e.g., MDR, ISO 13485).
  • Evaluate technical documentation, quality management systems, and manufacturing processes.
  • Prepare detailed audit reports, outlining findings, non-conformities, and recommendations for corrective actions.
  • Collaborate with cross-functional teams to ensure consistent and thorough audit processes.
  • Stay updated on changes in medical device regulations and standards to provide accurate and current guidance to clients.
  • Provide training and mentorship to junior auditors and other team members as needed.
  • Participate in internal and external meetings, representing the notified body with professionalism and expertise.
  • Support clients in understanding and implementing regulatory requirements.


Qualifications:


  • Bachelor's degree in engineering, biomedical sciences, or a related field; advanced degree preferred.
  • Certified Lead Auditor qualification in ISO 13485 and/or relevant medical device regulations.
  • Minimum of 5 years of experience in the medical device industry, with at least 3 years in a regulatory or quality assurance role.
  • In-depth knowledge of EU Medical Device Regulation (MDR), ISO 13485, and other relevant standards.
  • Strong analytical skills and attention to detail.
  • Excellent communication and interpersonal skills, with the ability to interact effectively with clients and regulatory authorities.
  • Proficiency in German and English, both written and spoken.
  • Ability to travel within Germany and internationally as required.

  • Senior Auditor

    Vor 5 Tagen

    Leipzig, Sachsen, Deutschland Grant Thornton Vollzeit

    About Grant ThorntonGrant Thornton is a leading audit, tax and advisory firm that helps dynamic organizations unlock their potential for growth. Our purpose is to build trust in the markets and to help our clients succeed.About the RoleWe are seeking a highly skilled Senior Auditor to join our team in Dresden, Germany. As a Senior Auditor, you will be...

  • Senior Auditor

    Vor 3 Tagen

    Leipzig, Sachsen, Deutschland Grant Thornton Vollzeit

    About Grant ThorntonGrant Thornton is a leading audit, tax and advisory firm that helps dynamic organizations unlock their potential for growth. Our purpose is to build trust in the markets and to help our clients succeed.About the RoleWe are seeking a highly skilled Senior Auditor to join our team in Dresden, Germany. As a Senior Auditor, you will be...

  • Senior Sustainability Auditor

    Vor 3 Tagen

    Leipzig, Sachsen, Deutschland Arcadis Vollzeit

    About the RoleWe are seeking a Senior Sustainability Auditor to join our team at Arcadis, a leading global consulting and engineering firm. As a Senior Sustainability Auditor, you will be responsible for leading and delivering sustainability projects, particularly in the context of the DGNB system.Key ResponsibilitiesLead and manage sustainability projects,...

  • Senior Sustainability Auditor

    Vor 5 Tagen

    Leipzig, Sachsen, Deutschland Arcadis Vollzeit

    About the RoleWe are seeking a Senior Sustainability Auditor to join our team at Arcadis, a leading global consulting and engineering firm. As a Senior Sustainability Auditor, you will be responsible for leading and delivering sustainability projects, particularly in the context of the DGNB system.Key ResponsibilitiesLead and manage sustainability projects,...

  • Senior-Auditor (m/w/d) - Karriereförderung

    Vor 4 Tagen

    Leipzig, Sachsen, Deutschland Genoverband e.V. Vollzeit

    Unser AngebotWir suchen einen erfahrenen Senior-Auditor, der sich in unserem Team einbringen möchte. Als Teil unseres Teams werden Sie an der Prüfungsplanung, Berichterstattung und Dokumentation entsprechend der berufsständischen Grundsätze mitwirken.QualifikationenBetriebswirtschaftliches Studium mit den Schwerpunkten Rechnungswesen, Steuern,...

  • DGNB Auditor Lead

    Vor 5 Tagen

    Leipzig, Sachsen, Deutschland Arcadis Vollzeit

    About the RoleWe are seeking a Senior Sustainability Auditor to join our team at Arcadis, a leading global consulting and engineering firm. As a Senior Sustainability Auditor, you will be responsible for leading and delivering sustainability projects, particularly in the context of the DGNB system.Key ResponsibilitiesLead and manage sustainability projects,...

  • DGNB Auditor Lead

    Vor 3 Tagen

    Leipzig, Sachsen, Deutschland Arcadis Vollzeit

    About the RoleWe are seeking a Senior Sustainability Auditor to join our team at Arcadis, a leading global consulting and engineering firm. As a Senior Sustainability Auditor, you will be responsible for leading and delivering sustainability projects, particularly in the context of the DGNB system.Key ResponsibilitiesLead and manage sustainability projects,...

  • Senior Auditor

    vor 4 Wochen

    Leipzig, Sachsen, Deutschland Grant Thornton Vollzeit

    We are seeking a committed Senior Auditor (m/w/d) to enhance our Audit & Assurance division in Dresden. This position is ideal for individuals passionate about providing exceptional services to clients within the Health Care industry.Provide independent advisory and support services to our varied, internationally oriented clientele, particularly in the...

  • Senior Auditor

    vor 4 Wochen

    Leipzig, Sachsen, Deutschland Grant Thornton Vollzeit

    We are seeking a committed Senior Auditor (m/w/d) to enhance our Audit & Assurance division in Dresden. This position is ideal for individuals who are passionate about providing exceptional services to clients within the Health Care industry.Provide independent advisory and support services to our varied, internationally oriented clientele, with a...

  • Senior Internal Auditor

    vor 2 Wochen

    Leipzig, Deutschland IU Internationale Hochschule Vollzeit

    **Wachse mit uns - starte Deine Karriere bei der IU!** Verstärke unser **Audit > Compliance** **-Team** ab sofort in **Voll**zeit **(40 Std./Woche) als **Senior Internal Auditor (m/w/d) **an einem unserer Standorte in München, Hamburg, Berlin, Kölnoder im **Homeoffice**. **Deine Aufgaben**: - Du planst, führst durch und berichtest eigenständig über...

  • Senior Auditor in Health Care Sector

    vor 4 Wochen

    Leipzig, Sachsen, Deutschland Grant Thornton Vollzeit

    We are seeking a committed Senior Auditor (m/w/d) to enhance our Audit & Assurance division in Dresden. This position is ideal for individuals who are passionate about providing exceptional services to clients within the Health Care industry.Provide independent advisory services and support to our varied, internationally oriented clientele, focusing on...

  • Senior Auditor

    Vor 3 Tagen

    Leipzig, Sachsen, Deutschland ETL-Gruppe Vollzeit

    About UsWe are a leading provider of financial services and solutions, with a strong focus on innovation and customer satisfaction.Our company, ETL-Gruppe, has a long history of excellence in the field of financial services, with over 50 years of experience in developing and implementing cutting-edge software solutions and IT services.We are a team of...

  • Senior Auditor

    Vor 5 Tagen

    Leipzig, Sachsen, Deutschland ETL-Gruppe Vollzeit

    About UsWe are a leading provider of financial services and solutions, with a strong focus on innovation and customer satisfaction.Our company, ETL-Gruppe, has a long history of excellence in the field of financial services, with over 50 years of experience in developing and implementing cutting-edge software solutions and IT services.We are a team of...

  • Sustainability Expert

    Vor 3 Tagen

    Leipzig, Sachsen, Deutschland Arcadis Vollzeit

    About the RoleWe are seeking a Senior Sustainability Auditor to join our team at Arcadis, a leading global consulting and engineering firm. As a Senior Sustainability Auditor, you will be responsible for leading and delivering sustainability projects, particularly in the context of the DGNB system.Key ResponsibilitiesLead and manage sustainability projects,...

  • Sustainability Expert

    Vor 5 Tagen

    Leipzig, Sachsen, Deutschland Arcadis Vollzeit

    About the RoleWe are seeking a Senior Sustainability Auditor to join our team at Arcadis, a leading global consulting and engineering firm. As a Senior Sustainability Auditor, you will be responsible for leading and delivering sustainability projects, particularly in the context of the DGNB system.Key ResponsibilitiesLead and manage sustainability projects,...

  • Business Consultant

    Vor 5 Tagen

    Leipzig, Sachsen, Deutschland Grant Thornton Vollzeit

    About Grant ThorntonGrant Thornton is a leading audit, tax and advisory firm that helps dynamic organizations unlock their potential for growth. Our team of experts provides innovative solutions to complex business challenges, enabling our clients to make informed decisions and achieve their goals.About the RoleWe are seeking a highly skilled Senior Auditor...

  • Business Consultant

    Vor 3 Tagen

    Leipzig, Sachsen, Deutschland Grant Thornton Vollzeit

    About Grant ThorntonGrant Thornton is a leading audit, tax and advisory firm that helps dynamic organizations unlock their potential for growth. Our team of experts provides innovative solutions to complex business challenges, enabling our clients to make informed decisions and achieve their goals.About the RoleWe are seeking a highly skilled Senior Auditor...

  • Senior Auditor in Health Care Sector

    vor 4 Wochen

    Leipzig, Sachsen, Deutschland Grant Thornton Vollzeit

    We are seeking a skilled Wirtschaftsprüfer (m/w/d) to enhance our Audit & Assurance division in Dresden. This position is ideal for individuals passionate about providing exceptional services to clients in the Health Care industry.Key Responsibilities:Provide independent advisory and support to a diverse range of international clients, particularly in the...

  • (Senior) Consultant Notfall- und Business Continuity Management

    vor 3 Monaten

    Leipzig, Deutschland adesso SE Vollzeit

    Standorte Aachen, Berlin, Bonn, Bremen, Dortmund, Dresden, Düsseldorf, Essen, Frankfurt, Hamburg, Hannover, Jena, Karlsruhe, Köln, Leipzig, München, Münster, Nürnberg, Paderborn, Potsdam, Saarbrücken, Siegen, Stralsund, Stuttgart, Ulm, Walldorf DEINE ROLLE - DAS WARTET AUF DICH Als Schlüsselspielerin oder Schlüsselspieler für unseren...

  • Erfahrener Wirtschaftsprüfer

    vor 4 Wochen

    Leipzig, Sachsen, Deutschland Grant Thornton Vollzeit

    Ihre Stärken. Unsere gemeinsame Wirkung. Bei Grant Thornton setzen wir auf Wirkung. Im Bereich Audit & Assurance gehören wir zu den führenden Wirtschaftsprüfungsgesellschaften in Deutschland. Unser Team vereint Fachkompetenz, aktuelle Erkenntnisse und professionelle Leidenschaft, um innovative Lösungen für unsere Mandanten zu entwickeln. Wir...