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- Perform 3rd-party audits and trainings according to ISO/IEC 27001, ISO 9001, ISO 20000-1, ISO 22301 & other IT specific standards/ frameworks
- Provide timely and accurate reviews of client’s corrective action and closure
- Provide customers with timely, complete, and accurate reports of their current level of conformity / implementation of their management system
- Maintain schedule of audit activity with Management System clients
- Maintain appropriate auditor credentials and pursues advancement of those credentials and other related credentials as needed.
- Ensuring compliance with accreditation rules and other internal or external requirements.
- Ability to manage Key Customers.
- Supporting the sales team on technical aspects.
- Familiarity with use of digital tools
- Conduct professional Audits / Trainings in line with DNV Philosophy
- Ensure timely deliverables such as Reports and updating the same in Auditor App
- Support DNV BA efficiency projects in optimalilty Travel, Audits / Trainings and Non refundable activities
- Prioritise key customers and represent DNV BA professionally for delivery.
- Ensure customer relations and resolve any customer complaints/concerns timely
- Prompt in submitiing time sheets & expenses statements
- Resolve in a speedy Manner the technical review issues if any so that the lead to customer is optimised
- Verify draft certificates for accuaracy.
- Support on crdeit collections by contacting the key account to resolve any issues, if required by Business Support staff
- Support Operations Planning & Scheduling by timely communication on dates for delivery for various services
- Support operations by proactive scheme qualification and Nace Code competence approvals to enable faster scheduling of audits / training
- Generate leads & opprtunities across services and pass on to sales
- Support Sales Team for QCT if required.
DNV MEDCERT is an accredited Certification Body for ISO 13485, recognised auditing organization under MDSAP and approved Notified Body for Medical Devices Regulation. We provide global market access by certifying the safety and quality of products and systems to international safety and quality standards and regulations. Our high professional standards and our sustainable approach guarantee you a forward-thinking work environment, within an organisation that invests in its employees, and is committed to providing you with continued development.
Medical Devices – Product Assurance
The production of medical devices is a strictly regulated business. DNV MEDCERT is a Notified Body, providing services that secure our customers’ market access around the world. We assist the industry in ensuring medical devices are safe, effective and of the highest standard and quality.
We are expanding our team in Hamburg and now seeking an experienced professional to join us as Medical Devices Certification Manager. The successful candidate will be responsible for liaising with Competent Authorities, and DNV MEDCERT customers, as well as providing assistance and guidance to Lead Auditors/Assessors in all process related activities.
Main responsibilities include:
- Management of Certification Body according to the relevant regulatory and normative requirements
- Final release of certification projects, execution of certification decision according to DNV MEDCERT certification requirements
- Interaction with Competent Authorities, the Commission and other notified bodies
- Planning and conducting audits against the manufacturing of medical devices, in accordance with ISO 13485, MDD 93/42/EEC, MDR 745/2017 and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.
- Ensuring that audits are conducted in a competent way and within requirements from authorities, leading to satisfied customers.
Primary Function:
To carry out and deliver the services to our customer in an efficient and professional manner as required by his Team Leader and/or formal agreements with clients.
Responsibilities:
- Responsible to meet his/her own KPI-targets
- to carry out the work for DNV in an efficient and professional manner
- to be responsible for quality of his/her own work
- to contribute positively to teambuilding processes
- to plan and execute audits, report findings and follow-up when necessary, within agreed time scales and economic frameworks under the supervision of the Lead Auditor
- to ensure that the independent nature of the Management System Certification scheme is not compromised or jeopardized at any time
- to be service minded and commercially active towards customers
- to ensure that DNV ’s Customer Relationship Management Programs is properly implemented
- to maintain his/her auditor qualification under the Registration Schemes as required by DNV. This registration scheme may be operated by DNV in-house or by industrial institution (e.g. CCAA, IRCA, IATF etc.)
- to update CV (both English and Chinese) and assessment log on an annual basis
- to submit timesheets & expense statements in TEAM system timely and accurately
Om DNV och rollen
Kom till DNV, ett världsledande certifieringsorgan, och gör avtryck som Global Lead Auditor/Projektledare. Som en del av vårt innovativa team kommer du att hjälpa företag att uppnå framgång och förtroende hos intressenter genom certifiering, verifiering, bedömning och utbildningstjänster. Genom att samarbeta med våra kunder kan du bidra till att skapa hållbara lösningar hos våra kunder och derasinressenter.
Som ett led i vår fortsatta tillväxt så letar vi efter kvalificerade multi-revisionsledare inom standarder såsom ISO 9001, 14001, 45001 och önskvärt 27001.
Arbetsuppgifter
Som Global Lead Auditor/Projektledare kommer du att arbeta självständigt och i multidisciplinära team. Leda globala nyckelkundsprojekt, samordna projekt, ta fram revisionsplaner, utföra revisioner, rapportera och följa upp revisioner och stötta försäljningen.
Du kommer att utföra revisioner och leda uppdrag inom flera standarder som ISO 9001, ISO 14001, ISO 45001 och önskvärt ISO 27001 inom en bred variation av branscher.
Join DNV, a world-leading certification body, and make your mark as a Global Lead Auditor/Project Manager. As part of our innovative team, you'll help businesses achieve excellence and stakeholder trust through certification, verification, assessment, and training services. Partnering with our customers, you´ll build sustainable business performance and create stakeholder trust across all types of industries.
As a result of further growth of our Business Assurance Unit in Sweden we are looking for qualified Lead auditors within the multiple management system standards such as ISO 9001, 14001, 45001 and desirable 27001. At DNV, we lead the way in various industries, solving risk and safety challenges for top companies. Collaborate with experts from diverse fields, broaden your skills, and make a global impact.
Tasks May Include
As a Global Lead Auditor/Project Manager, you'll work independently and with multidisciplinary teams. Lead global key customers, manage contract execution, coordinate projects, develop audit plans, conduct audits, manage larger certification projects, support sales, and contribute to revenue.
You will perform audits and lead assignments within multiple standards such as ISO 9001, ISO 14001, ISO 45001 and ISO 27001 – normally at the customer’s premises - in a wide variety of industries.
Som ett resultat av vår starka tillväxt i Sverige söker vi kvalificerade informationssäkerhetsrevisorer. I denna roll ser vi att du genom din gedigna kunskap inom ISO 27001 (gärna i kombination med ISO9001) bidrar till att höja våra kunders nivå inom informationssäkerhet.
Tjänsten är öppen för placering över hela Sverige. Det mesta av jobbet sker hos kunden så möjlighet att resa är ett krav.
Du
Som revisionsledare är du en del av ett mycket erfaret team av 70 underleverantörer och 12 anställda revisorer som arbetar över ett brett spektrum av branscher. Du kommer arbeta såväl på egen hand som i team med kollegor från olika kompetensområden.
Inom DNV som utgör en internationell organisation förutsätter vi att du har goda kommunikativa egenskaper och ett starkt affärstänkande, du är anpassningsbar inför olika situationer och målgrupper. Du är välorganiserad, service-minded med leveransfokus mot hög kvalitet inom överanskomna ramar. Du sätter kundens behov i första rummet och ser till att bibehålla DNVs goda renommé.
Tjänsten kräver att du reser i stor utsträckning – även på icke-kontorstid.
Vi erbjuder:
• En stark företagskultur med högt fokus på personlig kompetensutveckling
• Härliga kollegor som värdesätter teamwork och ömsesidig hjälpsamhet
• Konkurrenskraftig lön inklusive tjänstebil
• En internationell miljö – gällande såväl kunder som kollegor
• Flexibel arbetstid med fokus på balans mellan arbete/fritid
• Intressanta och krävande kunder, såväl inom som utanför Sverige
• Möjlighet att utvecklas i linje med dina ambitioner inom DNV
The Lead Auditor is a function in DNV Business Assurance Italy with the objective of leading the audit team in performing audits/assessment according to DNV standards and protocols, international standards or equivalent national standards and according to the established DNV methodologies/rules.
- Plan and execute audits, report findings and follow-up when necessary, within agreed times scales and economic frameworks.
- Carry out in efficient and competent manner the work for DNV as required by instructions/ the management system and/or as per formal agreement between the client and DNV.
- Ensure that the independent nature of the DNV scheme is not compromised at any time.
- Maintain/Acquire his/her Auditor Registration with DNV or any other registration having been a basis for his acceptance as Lead Auditor within DNV.
- Meeting professional practice standards and demonstrating competence in core areas.
- Developing and maintaining positive relationship with client personnel.
- Maintaining high morale by contributing to an effective positive work environment.
- Acting as a team player who works well with others and guides self through professional development process, including timely completion of reviews and goal setting.
- Maintaining effective communication with line management, between audit team members and client stakeholders.
- Lead, organize and deliver specific project activities as industry project management, Customer management assessment, gap analysis, training, workshops.
The role will also include typical back-office tasks in support to project management such as:
- Promptly contact customers to confirm the planned activities.
The Lead Auditor is a function in DNV Business Assurance Italy with the objective of leading the audit team in performing audits/assessment according to DNV standards and protocols, international standards or equivalent national standards and according to the established DNV methodologies/rules.
- Regular auditing field activities.
- Manage relationships clients and implement an approach of total customer focus.
- Carry out in efficient and competent manner the work for DNV as required by instructions/ Quality System and/or as per formal agreement between the client and DNV.
- Ensure that the independent nature of the DNV scheme is not compromised at any time.
- Maintain/acquire his/her Auditor Registration with DNV or any other registration having been a basis for his acceptance as Lead Auditor within DNV.
- Plan and execute audits, report findings and follow-up, when necessary, within agreed times scales and economic frameworks.
- Meet professional practice standards and demonstrate competence in core areas.
- Develop and maintain positive relationship with client personnel.
- Maintain high morale by contributing to an effective positive work environment.
- Act as a team player who works well with others and guides through professional development process, including timely completion of reviews and goal setting.
- Maintain effective communication with line management, between audit team members and client stakeholders.
- Ensure the correct use of production tools dedicated to auditing activities and the communication of updated data, in order to allow proper issue and management of certificates.
DNV Business Assurance North America is seeking an ISO 9001/14001/45001 Integrated Lead Auditor for our Management System service line. As third-party auditors, we assist clients of all sizes in achieving and maintaining internationally recognized certifications to guarantee the quality of their products.
This position is based out of our offices in AZ, FL, GA, IL, MI, MO, NE, OH, PA, TX, SC, NC, NJ, and Washington D.C. with travel up to 90%.
What You’ll Do
- Perform 3rd party onsite ISO 9001/14001/45001 audits for North America customers
- Provide timely and accurate reviews of customer corrective action and closure
- Provide customers with timely, complete, and accurate reports of their current level of compliance or implementation of their management system
- Document and report audit activities and results
- Interact directly with clients at all levels of management in developing timely, complete, and accurate report of their current level of compliance or implementation of their management system
- Will be assigned as a key customer project manager- coordinating audit project with other DNV regions
- Maintain schedule of audit activity
- Maintain appropriate auditor credentials and pursues advancement of those credentials and other related credentials as needed
- Contribute to the growth and development of a world-class, industry-leading auditing team
- Conduct 3rd party audits for AS 9100 and other management system certification audits in line with DNV Philosophy
- Generate leads & opportunities for AS 9100 Schemes and across services and pass on to sales
- Provide timely and accurate reviews of customer corrective action and closure
- Document and report audit activities and results
- Interact directly with clients at all levels of management in developing timely, complete, and accurate report of their current level of compliance or implementation of their management system
- Maintain schedule of audit activity with customers
- Maintain appropriate auditor credentials / qualifications and pursue advancement of those credentials and other related credentials as needed
- Support operations by proactive scheme qualification and NACE Code competence approvals to enable faster scheduling of audits / training
- Contribute to the growth and development of a world-class, industry-leading auditing team
- Provide sales support when required
As part of our continued growth, we are looking to recruit a technical and experienced Active Medical Device Assessor / Lead Auditor in Europe. The successful candidate will be responsible for planning and conducting audits / assessments against the manufacturing of medical devices, in accordance with ISO 13485, MDD 93/42/EEC, MDR 745/2017 and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.
Key Accountabilities:
- Conduct assessments (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
- Conduct Technical File reviews specific for products being authorized.
- Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business.
- Complete specific projects in relation to medical device procedures, processes, systems and documentation as requested by the Medical Devices Operations Manager.
- If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements.
- Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards.
Location: France
As an Aerospace Auditor, below are the job responsibilities:
- Perform 3rd party AS9100/ISO 9001audits for Japan customers
- Provide timely and accurate reviews of customer corrective action and closure
- Document and report audit activities and results
- Interact directly with clients at all levels of management in developing timely, complete, and accurate report of their current level of compliance or implementation of their management system
- Maintain schedule of audit activity with customers
- Maintain appropriate auditor credentials / qualifications and pursue advancement of those credentials and other related credentials as needed
- Contribute to the growth and development of a world-class, industry-leading auditing team
- Conducting AS9100 Foundation Training and Internal auditor course
- Provide sales support when required
- Perform the FSC audits in accordance with related FSC and DNV procedures.
- Effectively communicate with clients on site.
- Timely complete audit reports according to the agreed format.
- Timely communication with internal staff according to any significant events during an audit or client’s information including a significant change.
- Generate leads & opportunities across services and pass them to sales.
- Support Sales Team for QCT if required.
Objective of the role:
MEDCERT is an accredited Certification Body for ISO 13485, recognised auditing organization under MDSAP and approved Notified Body for Medical Devices Regulation. We provide global market access by certifying the safety and quality of products and systems to international safety and quality standards and regulations. Our high professional standards and our sustainable approach guarantee you a forward-thinking work environment, within an organisation that invests in its employees, and is committed to providing you with continued development.
Medical Devices – Product Assurance
The production of medical devices is a strictly regulated business. MEDCERT is a Notified Body, providing services that secure our customers’ market access around the world. We assist the industry in ensuring medical devices are safe, effective and of the highest standard and quality.
We are expanding our team and now seeking Sterilization Experts on either a full-time or freelance basis. The successful candidates will be responsible for planning and conducting audits based on the requirements of ISO 19011 and ISO 17021 and the accreditation rules for Certification Bodies of quality management systems within the scope of ISO 13485 and sterile medical products (issued by DAkkS)
MEDCERT is an accredited Certification Body for ISO 13485, recognised auditing organization under MDSAP and approved Notified Body for Medical Devices Regulation. We provide global market access by certifying the safety and quality of products and systems to international safety and quality standards and regulations. Our high professional standards and our sustainable approach guarantee you a forward-thinking work environment, within an organisation that invests in its employees, and is committed to providing you with continued development.
Medical Devices – Product Assurance
The production of medical devices is a strictly regulated business. MEDCERT is a Notified Body, providing services that secure our customers’ market access around the world. We assist the industry in ensuring medical devices are safe, effective and of the highest standard and quality.
We are expanding our team and now seeking Lead Auditors for Active & Non-active Medical Devices on either a full-time or freelance basis. The successful candidates will be responsible for planning and conducting audits against the manufacturing of medical devices, in accordance with ISO 13485, MDD 93/42/EEC, MDR 745/2017 and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.
Your primary tasks will include:
- Planning and conducting audits (locally & internationally) with the aim of ensuring product and management system compliance
- Ensuring that audits are conducted in a competent way and within requirements from authorities, leading to satisfied customers.
Objective of the role:
Manage, perform and deliver MDR and ISO13485 activities, assessment.
DNV Product Assurance AS is one of the leading Notified Bodies for medical devices. The unit is entitled to carry out tasks related to conformity assessment of medical devices with EU Medical Devices Regulation before such products are placed on the market.
The role of Internal Clinician is to assess clinical data supporting safety and performance of devices.
Main tasks in this role are:
- Approval of Certification Proposals for medical devices to be certified according to the Medical Device Regulation
- Performing assessment and preparing reports of clinical aspects of legal manufacturers technical documentation according to the requirements given in the Medical Device Regulation
- Evaluation of the summary of safety and clinical performance reports for high-risk medical devices
- Review and approval of clinical evaluation report and other relevant clinical documentation for accuracy and compliance with the requirements in the Medical Device Regulation
- Recommend for certification based on reviewed documentation
- Communication with the customers with regards to requirements, status and clinically relevant aspects
- Performing competence review of new resources (clinicians)
- Plan and execute assessment of clinical data as required, within agreed timescales and economic budget
What will you be doing
As Lead Auditor ICT (Information Security), you will conduct audits at our customers in the IT sector. You are a valuable discussion partner for our clients and support them in continuously improving business processes and operating results with the help of certification and training.
What do we offer?
We offer an independent, varied position with a lot of responsibility in an international environment, good employment conditions and extensive opportunities to work on your professional, personal development.
- Maintenance of your competences & qualifications
- Calibration workshops for auditors
- Build up (international) customer base
- Varied working weeks
- Expansion of your network
- You are part of a team of experienced and broadly qualified professionals
DNV's Healthcare Division is seeking to fill the role of Generalist Surveyor. This position can be remote from anywhere in the Continental U.S with travel to customer sites up to 100% of the time.
DNV Healthcare Division is the vanguard of quality improvement in the healthcare industry through promoting adoption and ensuring compliance with internationally recognized ISO 9001 quality management and NIAHO accreditation standards. Our teams of highly qualified healthcare professionals work as trusted partners with providers nationwide to ensure the highest quality and safest care.
What You'll Do
- Participate as a member of the healthcare survey team ensuring provider compliance with the guidelines, principles and written instructions established by DNV.
- Work independently to survey healthcare organizations throughout the United States.
- Apply analysis and reasoning skills to determine healthcare organizations’ degree of compliance with applicable standards and ISO principles.
- Prepares management reports linked to standard nonconformities with potential system(s) vulnerabilities and related organizational risk points.
- Effectively communicates (constructive and collegial) and engages with healthcare organization staff in interactive dialogues on standards-based issues to assess compliance and to identify opportunities for improving compliance.
- Where applicable, supervise the work and provide guidance and/or training to other survey team members.
- Attend monthly educational calls.
- Complete all required ongoing training and educational requirements.
- Participates in other DNV activities as assigned.