Lead Auditors and Assessors vacancy to perform third party audits and assessment of technical documentation as per DNV GL Certification procedures and the requirements of ISO 9001, ISO 13485 and the Medical Devices Directive
**This position can be located anywhere in India**
- Perform audits as an auditor or lead auditor, in conformance with the DNV GL Global/Local procedures. Lead, as necessary, a team of auditors.
- Access and review clients' medical devices quality systems and technical documentation to the requirements of ISO 9001, ISO 13485 and other regulatory requirements for access into EU. Review technical dossiers to the requirements of 93/42/EEC (MDD)
- Decide upon evidence gained during audits whether or not manufacturers are in compliance with all relevant standards / regulations, and if registration should be recommended or allowed to continue.
- Present Standard Training Courses and, upon approval, as a tutor deliver such courses as specified.
- Provide technical support to marketing and sales functions, where required.
- Conduct public presentations / seminars on specific standards, where required.
- Utilize professional communication and presentation skills while meeting with clients.
- Respond to client enquiries on all technical matters regarding DNV GL- certification / training products.
- Report any customer complaints, problems and or system deficiencies to the Regional Manager / Certification Management.
- Act professionally abiding by the non-disclosure agreement and DNV GL Codes of Integrity.
- Maintain competence and audit credentials by taking additional and/or refresher course(s), as necessary.
- Assist in the training of other auditors and lead auditors during planned audits or during other training functions.
- Participate actively in witness audits by DNV GL or accreditation bodies.
- Undertake any other activities as directed by the Regional Management.
- Have a minimum five years recent experience in the medical device sector
- Minimum Bachelor's Degree in Medicine, Science or Engineering, or equivalent. A PhD and/ or Clinical qualification is desirable. Experience / knowledge of research methodologies, literature search of medical publications and bio-statistical tools would be an advantage.
- Satisfactory completion of an IRCA / equivalent -approved training course in Quality auditing.
- Strong background in either design engineering or research and development
- Global Regulatory Affairs and Quality Assurance knowledge and practical experience, including MDD / IVDD
- FDA 510(k) experience is desirable.
- Experience of risk management and sterilization methods
- Have competent working knowledge of nationally recognized Quality Management System auditing standards and procedures.
- Broad knowledge of engineering and technical applications used in the development of medical devices.
- Strong assessment techniques knowledge (examination, question, evaluate, report)
- Ability to react effectively in stressful situations and make clear, well-founded decisions regarding conformity during the audit.
- Ability to handle multiple projects and delivering results on time
- Pro-active attitude and excellent organizational skills
- Excellent interpersonal, verbal, written and presentation skills
- Ability to travel extensively.
Company & Business Area Description
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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