Manager RA & QA in Hamburg bei DNV

DNV MEDCERT is an accredited Certification Body for ISO 13485, and auditing organization under MDSAP and designated 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.

Main responsibilities include:

• Compliance monitoring
• Oversight, including collection, internal dissemination and management, of information on the relevant designation, recognition and accreditation requirements for certification and conformity assessment programs
• Oversight of the management system’s provisions for safeguarding impartiality and confidentiality in accordance with these requirements
• Oversight, maintenance and further development of the management system
• Advising MD on the known compliance issues
• Regulatory liaison
• Oversight of MEDCERT’s ongoing designation, recognition and accreditation procedures at their different phases: application, assessment activities, reporting and decision making
• Liaising with designating/ / recognizing/ accreditation bodies, supporting their oversight activities
• Participation in committees and meetings, as required, as regards the continuous development of its auditing and conformity assessment programs
• Function as QMB (Qualified Medicare Beneficiary) or its supervision

• Competency Requirements:
  • Post-secondary education or equivalent work experience in engineering or natural science
  • Work experience in the field of regulated product and/or services, preferably in the management/ accreditation/ recognition/ designation of conformity assessment bodies and/or certification bodies
  • Meeting of requirements for the QMB function is requisite
  • Meeting of requirements of Annex C of IAF MD 9:2017 is an additional asset
  • EDP knowledge (Word, Excel, data base)
  • Knowledge of English (spoken and written) is required
  • High attention to detail
  • Strong communication skills
  • Ability to work independently, using own initiative, as well as a part of a team
  • Proactive and result-oriented approach

DNV is an independent assurance and risk management provider, operating in more than 100 countries. Through assessment and digital assurance solutions, DNV helps companies build trust and transparency around products, assets, supply chains and ecosystems.

Combining sustainability, supply chain and digital expertise, DNV works to create new assurance models enabling interaction and transaction transparency across value chains. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers.

Driven by its purpose, to safeguard life, property, and the environment, DNV helps tackle the challenges and global transformations facing its customers and the world today and is a trusted voice for many of the world’s most successful and forward-thinking companies.