Senior Quality Assurance Specialist

If you've spent years building and maintaining QMS frameworks in medical devices and you're ready to own one entirely, rather than be one voice in a large quality team, this is worth your attention.

The Company

This is a global healthcare technology company with over 80 years of experience in medical imaging, and healthcare has become one of its most strategically important areas. Across Europe, its teams work on everything from diagnostic imaging and endoscopy systems to healthcare IT and in vitro diagnostics, a portfolio that is growing and increasingly software-enabled.

The German entity operates as a distribution organisation within that wider European structure, and quality sits at the centre of how it operates. The team here is small and collaborative, not a sprawling quality department with layers of sign-off. Ideas are heard, and when they are good, they are acted on. The people who thrive in this environment take real ownership of their work rather than waiting to be directed.

This is also a stable place to build a career. Many colleagues have been with the business for two decades or more, which tells you something about the culture beyond what any job description can.

The Opportunity

Sitting as the standalone quality professional for the German distribution site, you will own the QMS in its entirety. That means being the person colleagues come to, the person who sets the standard, and the person who shapes how quality practice develops as the business grows and its portfolio expands.

Beyond the German operation, you will contribute to harmonising quality systems across European sites, which gives this Sr Quality Systems Specialist position a broader remit than a purely local role. As the organisation extends its software-as-medical-device capabilities, you will support the implementation of ISO/IEC 27001 alongside the ISO 13485 and ISO 9001 foundations you will already be bringing.

You will report into the German management structure and work in a hybrid arrangement, with the balance of office and remote time settled on a monthly basis. Your Japanese and international colleagues communicate in English, so you will be working in a genuinely international environment from day one.

The successful applicant will be someone who is self-sufficient by nature. If you have come from a highly structured, process-heavy corporate environment where every decision required committee approval, this will be a different experience. Here, you will have the autonomy to develop procedures, drive improvement, and build quality standards that genuinely stick.

What You'll Be Doing

• Own and drive the QMS for the German distribution organisation, acting as the primary quality authority on site.
• Maintain, develop and continuously improve the local management system in line with ISO 13485, ISO 9001 and ISO/IEC 27001 requirements.
• Develop and implement procedures that align the German site with wider European QMS harmonisation efforts.
• Manage all documentation, including procedures, records and version control, to keep the system audit-ready at all times.
• Raise, investigate and resolve nonconformities, CAPAs, customer complaints and deviations in a timely and methodical way.
• Plan, conduct and document internal audits and supplier audits, and coordinate certification body audits through to closure.
• Support cross-functional teams by translating quality and information security requirements into practical, workable processes.
• Contribute to future QMS and ISMS extension projects as the business broadens its portfolio across Europe.

What We're Looking For

• A degree in quality, engineering or a related discipline, with at least five years of hands-on quality systems experience in a medical device environment.
• Deep working knowledge of ISO 13485:2016 and ISO 9001:2015; familiarity with ISO/IEC 27001:2022 is a strong advantage.
• Proven experience preparing for and conducting internal and supplier audits, with the ability to produce clear, actionable audit reports.
• Fluent in German and English, both written and spoken, with the ability to work confidently in an international, cross-cultural team.