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Lead Auditor Medical Device DNV GL

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Main duties
The lead auditor needs to understand relevant international standards and practices, within the medical device area. Be fully chargeable with customer world. Contribute in identifying and pursuing ways to increase efficiency and effectiveness of audit procedures. Interpret new directives, policies, and procedures and communicate changes to appropriate staff. Able to manage multi-discipline projects.


The MD lead auditor shall
Audit the quality management system of an organization to assure that the organization has implemented a system for quality management of its products, processes and services, in line with the organization's policy and the requirements in the management system standard and/or directive
• Be responsible for the whole audit process
• Contact the client minimum 2 months in advance to identify any changes, which may change audit time or place
• Prepare the certification proposal for approval in due time before the audit
• Plan and organize the audit time by communicating with the client and audit team
• Prepare and send the audit plan to the client
• Inform the client and the audit team if there are changes in audit date or plan
• Conduct the opening and closing meetings for the audit
• Planning and conducting audits 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

 

Position Qualifications

The ideal candidate shall be in possession of:
• Qualifications in the schemes ISO 9001, ISO 13485.
• Knowledge of the regulatory requirements for medical devices
• Knowledge in relation to external supplier audits/ internal audits
• BSc degree in the relevant product or medical device area for one or several technologies used in the medical device sector (educational requirement), or equivalent.
• Minimum 4 years of working experience in the relevant production technology from manufacturing of medical devices or from R&D position within medical devices
• A broad experience within the medical device sector
• Good and effective communication skills, in written words
• English language (fluent written and verbal)
• One of Scandinavian language (fluent written and verbal)
• Extensive travelling (50-60 %)
• Energy and Commitment to keep up with different business and management when auditing on-site
• Assertive approach, good organizational skills and orientation to customer satisfaction complete the profile, customer focuse / orientation.
• Structured, able to show initiative and to work independently

Location: Norway/ Sweden/ Denmark.

DNV GL is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity!


For more information please contact: Siv Inderdal Eklo, Regional Development Manager- Northern Europe, siv.eklo@dnvgl.com

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DNV GL is a global quality assurance and risk management company. Driven by our purpose of safeguarding life, property and the environment, we enable our customers to advance the safety and sustainability of their business.

We provide classification, technical assurance, software and independent expert advisory services to the maritime, oil & gas, power and renewables industries. We also provide certification, supply chain and data management services to customers across a wide range of industries.

Combining technical, digital and operational expertise, risk methodology and in-depth industry knowledge, we empower our customers’ decisions and actions with trust and confidence. We continuously invest in research and collaborative innovation to provide customers and society with operational and technological foresight.

With origins stretching back to 1864 and operations in more than 100 countries, our experts are dedicated to helping customers make the world safer, smarter and greener.

DNV GL is one of the world’s leading certification bodies. We help businesses assure the performance of their organizations, products, people, facilities and supply chains through certification, verification, assessment, and training services. Partnering with our customers, we build sustainable business performance and create stakeholder trust across all types of industries.

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Main duties
The lead auditor needs to understand relevant international standards and practices, within the medical device area. Be fully chargeable with customer world. Contribute in identifying and pursuing ways to increase efficiency and effectiveness of audit procedures. Interpret new directives, policies, and procedures and communicate changes to appropriate staff. Able to manage multi-discipline projects.


The MD lead auditor shall
Audit the quality management system of an organization to assure that the organization has implemented a system for quality management of its products, processes and services, in line with the organization's policy and the requirements in the management system standard and/or directive
• Be responsible for the whole audit process
• Contact the client minimum 2 months in advance to identify any changes, which may change audit time or place
• Prepare the certification proposal for approval in due time before the audit
• Plan and organize the audit time by communicating with the client and audit team
• Prepare and send the audit plan to the client
• Inform the client and the audit team if there are changes in audit date or plan
• Conduct the opening and closing meetings for the audit
• Planning and conducting audits 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

 

Position Qualifications

The ideal candidate shall be in possession of:
• Qualifications in the schemes ISO 9001, ISO 13485.
• Knowledge of the regulatory requirements for medical devices
• Knowledge in relation to external supplier audits/ internal audits
• BSc degree in the relevant product or medical device area for one or several technologies used in the medical device sector (educational requirement), or equivalent.
• Minimum 4 years of working experience in the relevant production technology from manufacturing of medical devices or from R&D position within medical devices
• A broad experience within the medical device sector
• Good and effective communication skills, in written words
• English language (fluent written and verbal)
• One of Scandinavian language (fluent written and verbal)
• Extensive travelling (50-60 %)
• Energy and Commitment to keep up with different business and management when auditing on-site
• Assertive approach, good organizational skills and orientation to customer satisfaction complete the profile, customer focuse / orientation.
• Structured, able to show initiative and to work independently

Location: Norway/ Sweden/ Denmark.

DNV GL is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity!


For more information please contact: Siv Inderdal Eklo, Regional Development Manager- Northern Europe, siv.eklo@dnvgl.com

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