Lead Auditor Medical Devices

DNV Germany Holding GmbH; United Kingdom; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading international certification body in the United Kingdom is looking for an experienced auditor to lead international audits under ISO standards. Responsibilities include planning audits, conducting assessments, and reporting results. The ideal candidate has an academic background in engineering or natural science, along with at least 4 years of experience in medical device processes. Proficiency in German and English is essential for this role.

Qualifications

• 4+ years experience in design or application of medical devices.
• Knowledge of quality management systems for CE-marking.

Responsibilities

• Plan and conduct audits under ISO 13485, MDR, and MDSAP.
• Document audit results per accreditation requirements.
• Report to the Audit Team Leader.

Skills

Planning and conducting international audits

Technical documentation assessments

Good communication skills (German and English)

Cross-cultural collaboration

Education

Academic degree in Engineering or Natural Science

Job description

Overview

Your primary tasks will include:

• Planning and Conducting international Audits under ISO 13485, MDR and MDSAP
• Conducting Technical Documentation assessments per competence profile.
• Documenting Audit results per Accreditation / Designation requirements.
• Develop and support the company culture within the Audit department
• Responsible for reporting to the Audit Team Leader

DNV 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.

Qualifications

• An academic degree in Engineering or any Natural Science
• At least 4 years work experience in the design, manufacturing, testing or application of medical devices
• Knowledge of quality management system certification and regulatory requirements for CE-marking
• Good communication skills (German and English)
• Ability to initiate and maintain cross-cultural collaboration

Please note that we cannot proceed to the interview stage without the following documents: Curriculum Vitae (CV); Cover- /Motivation Letter; University Diplomas & Transcripts; Reference Letter(s). All documents shall preferably be submitted in English. Please provide them at your earliest convenience to ensure a smooth and timely assessment process. Your cooperation in this matter is greatly appreciated.