Position: Senior Quality Engineer
Type: Permanent
Location: Munich
A growing medical device manufacturer is seeking a Senior Quality Engineer to support the implementation and development of a Quality Management System (QMS). This role is critical to ensuring compliance with EU regulations for medical devices, including for SaMD and AI for medical devices.
Senior Quality Engineer – Key Responsibilities:
* Lead the implementation and continuous improvement of the QMS in accordance with ISO 13485 and EU MDR.
* Collaborate with cross-functional teams to integrate quality processes into product development.
* Prepare and maintain documentation for audits, inspections, and regulatory submissions.
* Support risk management activities and design control processes throughout the product lifecycle.
Senior Quality Engineer – Requirements:
* Proven experience in quality engineering within the medical device or SaMD sector.
* Strong knowledge of ISO 13485, EU MDR, and applicable AI/ML regulatory frameworks.
* Familiarity with IEC 62304, IEC 42001, and other relevant standards.
* Excellent communication and documentation skills
* Ability to work independently and collaboratively in a fast-paced, innovative environment.
If you're a quality-driven professional ready to shape the future of digital health, apply to Lauren Park at X4 Group or connect with Lauren to stay informed about X4 Group’s latest opportunities.