Quality Assurance Consultant
Quality Assurance Consultant - Medical Device Development (Hamburg 🇩🇪)
A 12‑month opportunity to support a global leader in minimally invasive medical‑device technologies, including complex optical systems, endoscopic instruments, and energy‑based surgical solutions. This assignment focuses on strengthening operational quality, documentation, product lifecycle support, and compliance within an ISO 13485-regulated environment.
📍 Location: Hamburg (Hybrid)
📅 Contract: 12 months
🚀 Start: March
Your Role
You will play a key role in supporting quality and compliance activities across instrumentation, imaging platforms, accessories, and reprocessing technologies. Your work will ensure that quality processes, documentation, and decisions remain aligned with regulatory expectations as well as internal standards for safety, performance, and reliability.
Key responsibilities include:
- Supporting quality activities for endoscopic instruments, imaging systems, accessories, and surgical-energy products throughout development and lifecycle phases.
- Maintaining and improving ISO 13485‑aligned QMS documentation, including SOPs, WI, forms, and controlled records.
- Reviewing and coordinating technical documentation, including product specifications, risk management files, IFUs, and verification/inspection evidence.
- Providing quality oversight during product updates, component changes, supplier‑related adjustments, and continuous‑improvement initiatives.
- Supporting complaint handling, root-cause analysis, and CAPA activities linked to hardware, optics, sterilisation, reprocessing, and device usability.
- Collaborating closely with engineering, manufacturing, service, and regulatory teams to ensure consistent quality standards across all product families.
- Ensuring readiness for internal and external audits, including documentation checks, traceability reviews, and alignment with global quality procedures.
Key Requirements
✅ Must‑have: Proven experience within a medical‑device company operating under ISO 13485.
✅ Strong knowledge of instrumentation, optical devices, electromechanical systems, or other hardware‑centric medical technologies.
✅ Experience with technical documentation, risk management, complaint/CAPA processes, and traceability requirements.
✅ Deep understanding of QMS principles, documentation control, and lifecycle quality activities.
✅ Comfortable working within a hybrid cross‑functional structure across engineering, production, service, and quality teams.
📤 Interested?
Send your CV and availability, profiles will be reviewed and shared with the client on a rolling basis as they are received.
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