Sr. Auditor (German speakers)

Company Description K Line Europe GmbH is Europe’s largest OEM clear aligner manufacturer, headquartered in Düsseldorf, Germany. The company operates across two modern production halls with a capacity of up to 6 million aligners per year. All products are CE certified, FDA approved, and manufactured under ISO13485-compliant quality standards. With a focus on innovation, reliability, and “100% Made in Germany” production, K Line Europe supports dental and orthodontic partners across Europe and beyond.

Role Description This is a full-time remote role for a Senior Auditor (German speakers). The Senior Auditor is responsible for planning and executing internal audits across financial, operational, and compliance areas, with a strong focus on quality and regulatory requirements in medical device manufacturing. Daily tasks include reviewing processes and documentation, testing controls, identifying risks, and preparing clear audit reports with practical recommendations for improvement. The role involves collaborating with cross-functional teams, supporting corrective and preventive action plans, and monitoring the implementation of agreed measures. The Senior Auditor also contributes to continuous improvement initiatives, helps maintain audit methodologies aligned with international standards, and communicates audit findings in both German and English to stakeholders.

Qualifications

• Strong audit and compliance skills, including experience with internal audits, risk assessment, and control testing, ideally within medical devices or regulated manufacturing environments.
• Knowledge of quality and regulatory frameworks such as ISO13485, CE and FDA requirements, and familiarity with standard audit methodologies and tools.
• Excellent analytical and problem-solving abilities, with a structured approach to process review, documentation analysis, and reporting.
• Advanced German language skills (spoken and written) and good English communication skills for effective interaction with international teams and stakeholders.
• High level of accuracy and attention to detail, with the ability to manage multiple audits and deadlines independently in a remote setting.
• Proficiency with common office and data tools (e.g., Excel, Word, audit or ERP systems) and the ability to present findings clearly to technical and non-technical audiences.
• Bachelor’s degree in Accounting, Finance, Business, Engineering, or a related field; professional audit or quality certifications (e.g., CIA, CISA, ISO lead auditor) are an advantage.
• Experience in an international or multicultural work environment and a collaborative mindset to support continuous process improvement.