Quality & Operational Assistant – Medical Devices

Full-time | Home-based | Germany preferred

About the Role

MD-Clinicals is looking for a Quality & Operational Assistant to join our international team.

This is a unique hybrid role combining Quality Management (approximately 50%) with Project & Operational Support (approximately 50%) within the medical device industry.

Working closely with senior Quality personnel and the Operational Manager, you will contribute to our Quality Management System (QMS) while supporting project coordination, resource planning and day-to-day business operations.

You will also have the opportunity to explore how Artificial Intelligence, digital tools and automation can make Quality and operational processes smarter and more efficient.

We are not necessarily looking for someone with years of Quality or Medical Device experience. We are looking for someone who is organized, precise, proactive, tech-savvy and eager to learn and grow.

What You’ll Do

Quality Management & QMS

You will support the maintenance and continuous improvement of our Quality Management System, including:

• QMS activities related to ISO 9001 and ISO 13485
• Document control, SOPs, Quality records and internal databases
• CAPAs, Non-Conformities, audits, training records and supplier monitoring
• Quality KPIs, deadlines and periodic reporting
• Internal and external audit preparation
• Digitalization and automation of repetitive Quality processes
• Exploration and testing of AI-assisted Quality tools and workflows

Project & Operational Support

You will help keep our projects and internal operations running efficiently by supporting:

• Project management systems and project data
• Project progress, milestones, budgets and task tracking
• Resource allocation, workload and billability monitoring
• Coordination with project managers and internal teams
• Vendor quotations, invoices and operational documentation
• Coordination with external service providers and accounting partners
• Operational reporting and follow-up of deadlines and action items
• Process improvement and automation using digital and AI tools

What We’re Looking For

We would like to meet someone who has:

• A university degree or equivalent education, preferably in a scientific, technical, business, operations, administrative or related field
• Excellent organizational skills and strong attention to detail
• Good analytical and problem-solving skills
• The ability to manage multiple priorities and follow through on deadlines
• Good written and spoken English
• Good knowledge of Microsoft Excel, Word, PowerPoint and Outlook
• Confidence in learning new systems and digital tools
• A strong interest in AI, digitalization, automation and process improvement
• The ability to work independently while collaborating effectively with an international team
• A proactive, reliable and solution-oriented mindset

Nice to Have — But Not Required

Experience or knowledge in any of the following would be an advantage:

• ISO 9001 / ISO 13485
• Quality Management Systems (QMS)
• Medical Devices / MDR
• CAPA and Non-Conformity management
• Project management or ERP systems
• Resource planning, timesheets or project reporting
• Invoice, purchasing or vendor coordination
• ChatGPT, Microsoft Copilot, Claude or other generative AI tools
• Power Automate, Power BI or advanced Excel
• Document Management Systems
• Basic knowledge of databases, Python, SQL or APIs

You do not need to tick every box.

Previous professional experience with AI, programming, Quality Assurance or Medical Devices is not mandatory. Training and mentoring will be provided.

Grow With the Role

This position offers the opportunity to progressively build expertise across Quality Management, Medical Devices, Artificial Intelligence, Digitalization, Project Operations and Business Administration.

You will receive training and mentoring in areas such as ISO 9001, ISO 13485, QMS, auditing, CAPA management, controlled use of AI in a regulated environment, and internal project and resource management tools.

As you develop, the role may evolve toward increased responsibilities in Quality Management, QMS digitalization and automation, or project and business operations.

If you are curious, organized, comfortable with technology and motivated to grow in an international medical device environment, we would be happy to hear from you.

Candidates based in Germany are preferred.