Published : 03/07/2025
Location : Bad Vilbel
Career Level : Work experience
Entity : DQS Medical Devices GmbH
Type of employment : Full time
Reference number : DQS Med

GET TO KNOW US

Demanding. Competent. Dynamic: This is how we, DQS Medizinprodukte, see ourselves and the services we provide for our customers. We bundle our global expertise in the certification and notification of management systems and products for the medical industry in healthcare, health care and medical device safety. We are part of the international DQS Group with around 1,000 employees and over 2,500 highly qualified and experienced auditors. Our core competencies lie in the implementation of customized certification audits and assessments. We focus on forward-looking topics such as sustainability, safety and quality. This makes us one of the world’s leading providers, with the aim of setting new standards in reliability, quality and customer focus at all times with our highly qualified team.

Your tasks

• Evaluation of the technical documentation (TD review) of medical devices under MDR.
• Conducting audits according to MDR, ISO 13485, and MDSAP if applicable.
• Assessment of changes to products and QM systems, SSCPs, PSURs, and vigilance, as part of continuous surveillance.
• Preparation of audit programs and sampling plans, allocation of resources, verification of applications, classification, coding, etc.
• Participation in conformity assessment procedures, especially for complex or novel medical devices.
• Liaising with internal and external experts (e.g. clinical experts, risk assessors).
• Support with enquiries from authorities, participation in inspections by ZLG, DAkkS and SCC if necessary.
• Support for internal improvement measures.

Your profile

• Completed studies in a relevant field (e.g. medical technology, biomedicine, engineering, natural sciences).
• Several years of professional experience (> 4 years) in the development, manufacture, testing or quality assurance of active or non-active medical devices.
• Ideally several years (>10 years) of professional experience as an auditor and/or product assessor at a Notified Body for the MDR Regulation (EU) 2017/745. Your professional experience demonstrably covers a wide range of medical devices (MDA and/or MDN codes) and technologies (MDT codes).
• In-depth knowledge of MDR, ISO 13485, ISO 14971, ISO 10993, IEC 62304, IEC 62366-1, IEC 60601, ISO 14155, MDSAP documents, as well as other regulatory requirements, MDCG guidelines and product standards.
• Recognized and proven qualifications as Lead Auditor for MDR, ISO 13485 and ideally MDSAP.
• Strong ability to assess complex technical and clinical issues.
• Fluency in written and spoken German and English.
• High degree of personal responsibility, objectivity and professional communication.
• Willingness to travel internationally (as required)

Why us?
A high-performing and friendly team, a collegial, systematic inductiontraining and interesting further training opportunities. In addition, an attractive, performance-related salary, opportunities to get involved and developand development and pleasant working conditions in an international, modern environment.
Jobticket
Jobrad
30 days vacation
Hybrid working: office and remote

DQS MEDIZINPRODUKTE GMBH - GET TO KNOW US

Demanding. Competent. Dynamic: this is how we, DQS Medizinprodukte, see ourselves and the services we provide for our customers. We bundle our global expertise in the certification and notification of management systems and products for the medical industry in healthcare, health care and medical device safety. We are part of the international DQS Group with around 1,000 employees and over 2,500 highly qualified and experienced auditors. Our core competencies lie in the implementation of customized certification audits and assessments. We focus on forward-looking topics such as sustainability, safety and quality. This makes us one of the world’s leading providers, with our highly qualified team setting new standards in reliability, quality and customer focus at all times.

• Evaluation of the technical documentation (TD review) of medical devices under MDR.
• Conducting audits according to MDR, ISO 13485, and MDSAP if applicable.
• Assessment of changes to products and QM systems, SSCPs, PSURs, and vigilance, as part of continuous surveillance.
• Preparation of audit programs and sampling plans, allocation of resources, verification of applications, classification, coding, etc.
• Participation in conformity assessment procedures, especially for complex or novel medical devices.
• Liaising with internal and external experts (e.g. clinical experts, risk assessors).
• Support with enquiries from authorities, participation in inspections by ZLG, DAkkS and SCC if necessary.
• Support for internal improvement measures