Lead Auditor Medical Devices

TN Germany; Hamburg; Vor Ort; EUR 50.000 - 80.000; Vollzeit

Zusammenfassung

An established industry player is seeking a qualified auditor to enhance its Audit department. In this pivotal role, you'll plan and conduct international audits under ISO 13485, MDR, and MDSAP standards, ensuring compliance and quality management. Your expertise will help shape the company culture while you collaborate across diverse teams. If you are passionate about quality assurance in the medical device sector and thrive in a diverse environment, this is an exciting opportunity to make a significant impact.

Qualifikationen

• 4+ years of experience in medical device design, manufacturing, or testing.
• Strong knowledge of quality management systems and CE marking.

Aufgaben

• Plan and conduct international audits under relevant standards.
• Document audit results to meet accreditation requirements.

Kenntnisse

Auditing

ISO 13485

MDR

MDSAP

Technical Documentation Assessment

Cross-Cultural Collaboration

Communication Skills (German and English)

Ausbildung

Degree in Engineering

Degree in Natural Science

Jobbeschreibung

Job Description

We are seeking a qualified auditor to join our team. Your primary responsibilities will include:

1. Planning and conducting international audits under ISO 13485, MDR, and MDSAP standards.
2. Conducting technical documentation assessments in accordance with your competence profile.
3. Documenting audit results to meet accreditation and designation requirements.
4. Developing and supporting the company culture within the Audit department.
5. Reporting directly to the Audit Team Leader.

Qualifications

• An academic degree in Engineering or any Natural Science.
• At least 4 years of 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 in German and English.
• Ability to initiate and maintain cross-cultural collaboration.

Additional Information

DNV is an Equal Opportunity Employer and considers all 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.