Requirements at a glance

University degree (Required)
5+ years quality experience (Required)
ISO 13485 (Required)
Internal auditor qualification (Preferred)
German and English (Required)
Medical device industry experience (Preferred)
Dot Compliance (Preferred)
Epicor (Preferred)
Team leadership (Required)

RequiredPreferred

Today

Manager Quality Systems

Location: Radolfzell, DEU

AT NDI, THE WORK YOU DO HERE MAKES A DIFFERENCE.

Every day, your work supports the advancement of medical technology. NDI is the recognized global leader and industry pioneer of Optical and Electromagnetic tracking technology. Backed by decades of innovation and expertise, we’re the strategic partner of choice for the world’s top medical device OEMs, advancing the development of OEM navigation platforms. Leading OEM navigation platforms rely on our technologies for accuracy and reliability across demanding applications, and as a strategic partner, we support them from concept through integration to commercialization.

Whether you're designing technology, supporting customers, or enabling the teams behind them, your work matters. Every role at NDI plays a part in shaping the future of medical technology innovation.

TASKS

Lead and manage the Quality Engineering team, plan workloads, capacity and priorities, and ensure your team members have the necessary qualifications and opportunities for professional development.
Maintain and continuously improve our quality management system. Working with Regulatory Affairs, translate ISO 13485 and applicable regulatory requirements into our processes, close compliance gaps and support consistent quality standards across sites.
Develop and update SOPs, process descriptions and work instructions, and coordinate their approval, associated training and timely implementation. You will also be responsible for document control, QMS change management and the administration of Dot Compliance.
Plan and manage the audit programme, conduct internal and supplier audits, and support customer and certification audits. Systematically assess findings and follow up on associated actions to ensure timely and effective closure.
Lead the CAPA process and ensure systematic root cause analyses and effectiveness checks. Manage deviations and supplier corrective action requests (SCARs) using a structured approach, working with the responsible functions to follow up on root causes and actions.