Senior Lead Auditor – In-vitro diagnostic medical devices

5 dagen geleden

Sittard, Nederland SGS Voltijd
Job Description

We currently have an exciting opportunity at SGS for an experienced lead auditor specialising in the EU In vitro diagnostic medical device regulation (IVDR). This role will support the expansion and development of the SGS IVDR certification service across our global network. As a senior expert you will be a key point of contact and mentor to colleagues and play a key role in the qualification of new auditors.

For this senior role, we seek candidates with previous experience as lead auditor within an IVDR notified body.

Key Accountabilities:

  • Support the development of the global SGS medical device auditor network by aiding the qualification of trainee auditors. This will involve witnessing of qualification audits, providing formal and informal feedback on trainee performance, delivering training and coaching.
  • Act as a key point of contact for the SGS medical device offices, a mentor for junior colleagues and help coordinate the expansion of the IVDR auditor network.
  • Contribute to the continuous improvement of the processes and tools used across the SGS network to conduct IVDR conformity assessment.
  • Conduct audits at clients’ sites and remotely, following established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
  • Work alone or lead audit teams as appropriate, enhance client satisfaction and ensure compliance with standards and regulatory requirements.
  • Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business.
  • Complete specific projects about medical device procedures, processes, systems and documentation as requested by the Medical Devices Manager.

Qualifications

For application, please submit English CV.

  • Previous auditing experience within an IVD or IVDR notified body is mandatory.
  • A minimum of 4 years ‘hands-on’ professional experience of designing, manufacturing or testing of IVDs.
    • At least 2 years of this experience should be in the field of quality assurance / quality management – this should be experience gained while working under a structured quality management system, in a role with responsibility for quality assurance/management.
  • A university degree or equivalent qualification in relevant sciences such as: Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Physics, Biophysics, Material Science Biomedical Engineering,  Mechanical, Electrical or Electronic Engineering, Computer & Software Technology.

Knowledge of:

  • EU IVDR 2017/746
  • Standards and guidance documents relevant to in-vitro diagnostic medical devices

In addition:

  • Experience of working under own initiative and in planning and prioritising workloads.  
  • Willingness to travel Internationally as required
  • Good English written and verbal skills

The following attributes would be desirable, but not essential:

  • Knowledge of and/or experience with other regulatory schemes and standard relevant to medical devices, such as IVDD, MDD, MDR, ISO 13485, MDSAP.
  • Work experience with medical devices other than IVDs.
  • Knowledge of additional European languages would be an advantage
  • Registered IRCA lead auditor, or equivalent registration under other recognised body.
  • Experience in delivering training and in engaging and working with people in all levels of an organisation.


Additional Information

We provide remote working environment.

  • Senior Lead Auditor – In-vitro diagnostic medical devices

    5 dagen geleden

    Sittard, Nederland SGS Voltijd

    Job Description We currently have an exciting opportunity at SGS for an experienced lead auditor specialising in the EU In vitro diagnostic medical device regulation (IVDR). This role will support the expansion and development of the SGS IVDR certification service across our global network. As a senior expert you will be a key point of contact and mentor...

  • Senior Software Engineer

    2 weken geleden

    Sittard, Limburg, Nederland Jumbo Supermarkten Voltijd

    About the Role:As a senior software engineer, you will lead the development of our cloud-based software solutions. Key Responsibilities:Design and develop cloud-based software applications.Lead a team of software engineers in software development.Collaborate with cross-functional teams to deliver software solutions.

  • Senior Software Engineer

    2 weken geleden

    Sittard, Limburg, Nederland Trixxo Voltijd

    About the RoleWe are seeking a highly skilled Senior Software Engineer to join our team. The ideal candidate will have a strong background in high-level development and be able to lead the implementation of large-scale software systems.Key Responsibilities:Design and develop high-quality software componentsCollaborate with cross-functional teams to identify...

  • Senior Software Engineer

    2 weken geleden

    Sittard, Limburg, Nederland Gom Voltijd

    Job Title: Senior Software Engineer - Cloud ArchitectureWe are seeking a skilled Senior Software Engineer to lead our cloud architecture efforts. As a key member of our technology team, you will design, develop, and deploy scalable cloud-based solutions that meet the needs of our business.Key Responsibilities:Design and develop cloud-based architectures that...

  • Senior GL Accounting Specialist

    4 weken geleden

    Sittard, Limburg, Nederland Boels Voltijd

    Job Title: Senior GL Accounting SpecialistWe are seeking a highly skilled Senior GL Accounting Specialist to join our team at Boels. As a Senior GL Accounting Specialist, you will be responsible for the performance and improvement of various processes within the financial accounting team.Key Responsibilities:Continuously improve processes and projects...

  • Senior Software Engineer for Large-Scale Systems

    2 weken geleden

    Sittard, Limburg, Nederland Maandag Voltijd

    About the JobWe are seeking a highly skilled and experienced Senior Software Engineer to join our team. The ideal candidate will have a strong background in systems programming and a proven track record of delivering large-scale systems.Key ResponsibilitiesDesign and develop complex software systemsLead technical teams and ensure high-quality codeCollaborate...

  • Quality Manager

    2 maanden geleden

    Sittard, Nederland Stamicarbon Voltijd

    The Company At Stamicarbon, the innovation and license company of MAIRE Group, we develop, design and license futureproof, innovative fertilizer plant technologies, with urea, green ammonia and nitric acid being our core businesses. Using more than 75 years of knowledge and experience, we offer our customers customized solutions and services to maintain,...

  • Accounts Payable Specialist

    3 weken geleden

    Sittard, Limburg, Nederland SABIC - Saudi Basic Industries Corp. Voltijd

    Job SummaryThis role is responsible for processing incoming invoices, preparing and checking payment runs, and contributing to the execution of other operational responsibilities within the Procure to Pay process. The ideal candidate will have a strong understanding of accounting principles, experience with SAP, and excellent analytical and problem-solving...

  • Quality Assurance Manager

    3 weken geleden

    Sittard, Limburg, Nederland Stamicarbon Voltijd

    Job Title: Quality Assurance ManagerAt Stamicarbon, we are seeking a highly skilled Quality Assurance Manager to join our team. As a Quality Assurance Manager, you will be responsible for implementing, maintaining, and continuously improving our Quality Management System and its related documented information.Key Responsibilities:- Facilitate middle...

  • Quality Assurance Manager

    3 weken geleden

    Sittard, Limburg, Nederland Stamicarbon Voltijd

    Job DescriptionAt Stamicarbon, we are seeking a highly skilled Quality Manager to join our team. As a Quality Manager, you will be responsible for implementing, maintaining, and continuously improving our Quality Management System and its related documented information.Key Responsibilities:Facilitate middle management in processes and procedures for...

  • Global Roles for Business Professionals

    2 weken geleden

    Sittard, Limburg, Nederland AXS Logistiek Venlo Voltijd

    About the Role:The company is seeking a highly skilled business professional to fill a senior position.Key Responsibilities:Lead business development initiativesDevelop and implement business strategiesManage a team of business professionalsAbout the Company:{company} is a global business leader with a strong presence in the industry.

  • Accounting Specialist for ESG Reporting and Compliance

    2 dagen geleden

    Sittard, Limburg, Nederland OCI Global Voltijd

    Company OverviewOCI Global is a leading global producer and distributor of ammonia, fertilizers, and methanol products. Our company provides essential fertilizers, lower-carbon fuels, and chemical feedstocks to agricultural, transportation, and industrial customers worldwide.We operate facilities in Europe, North Africa, the Middle East, and the US, and...

  • Senior E-commerce Project Coordinator

    4 weken geleden

    Sittard, Limburg, Nederland beBee Professionals Voltijd

    BeBee Professionals is looking for a seasoned E-commerce Project Manager to lead the development and implementation of e-commerce projects. The successful candidate will be responsible for managing the project from start to finish, ensuring that all tasks are completed on time and within budget.The ideal candidate should have:At least 5 years of experience...

  • Career Opportunities: Employee Accounting

    5 maanden geleden

    Sittard, Nederland OCI Nitrogen B.V. Voltijd

    OCI Nitrogen is the world’s largest producer of melamine and one of the market leaders in nitrogen fertilizers in Europe. When you join the OCI team, every day you get the chance to make a difference as you advance your career. You can also contribute to a sustainable living environment at OCI. With our melamine we provide sustainable products such as...

  • Talent Acquisition Manager Benelux

    4 weken geleden

    Sittard, Limburg, Nederland Boels Voltijd

    About BoelsBoels is one of the largest machine rental companies in Europe, with a strong presence in the Benelux region. As a family business, we value personal commitment and a pleasant working atmosphere. We're looking for a talented individual to join our team as a Talent Acquisition Manager Benelux.Job SummaryWe're seeking a highly motivated and...

  • Head Of International Marketing

    4 weken geleden

    Sittard, Limburg, Nederland Boels Voltijd

    Job Title: Head Of International MarketingWe are seeking a highly experienced and skilled Head of International Marketing to join our team at Boels Rental. As a key member of our marketing department, you will be responsible for developing and executing marketing strategies that drive business growth and expansion across Europe.Key Responsibilities:Develop...