Head of Quality / QMR

At Vivalyx, a medical technology startup based in Aachen, we're on a mission to save the lives of those suffering from organ failure. Our innovative approach aims to dramatically improve the vitality and availability of donor organs. As we gear up for certification and related studies, we're seeking dedicated team members (m/f/d) to join us starting as soon as possible, for 32-40 hours per week.

Tasks

As the Head of Quality and QMR, you will be responsible for maintaining and continuously improving our Quality Management System (QMS) in alignment with ISO 13485 and FDA 21 CFR Part 820 standards. You will play a critical role in ensuring the quality of our medical devices from design and development through to supplier quality management, manufacturing oversight, and risk management.

Key responsibilities:

• Quality Management System (QMS): Develop, implement, and maintain the QMS in compliance with ISO 13485, covering the scope of design, development, and manufacturing of medical devices.
• Compliance & Auditing: Conduct internal and supplier audits to ensure compliance with MDR, ISO 13485, FDA 21 CFR Part 820, and other relevant standards. Prepare the organization for external audits.
• Supplier Quality Management: Lead supplier quality audits, ensuring that all suppliers meet the necessary quality and regulatory requirements.
• Manufacturing Oversight: Ensure manufacturing processes align with quality standards, conducting regular quality checks and overseeing adherence to production protocols.
• Development Quality: Collaborate closely with the product development team to ensure that quality is embedded in every stage of the design and development process.
• Regulatory Quality: support the development and regulatory affairs team in risk management in accordance with ISO 14971 and follow up implementation of measures
• Proactive Problem Solving: Take ownership of the QMS, proactively identifying potential issues and implementing solutions to prevent quality problems before they arise. Drive continuous improvement initiatives across the organization.

Requirements

• Minimum of 3 years of experience in quality management, preferably within a startup or SME.
• Strong background in medical devices, with a full understanding of ISO 13485 and FDA 21 CFR Part 820.
• Excellent communication skills, with the ability to influence and drive quality initiatives across the organization.
• Flexibility to adapt to changing environments and requirements.

• Experience in a medical devices startup environment.
• Familiarity with supplier quality management and audit processes.
• Experience as internal and or/supplier auditor
• Experience in risk management, particularly with ISO 14971.
• Experience in regulatory affairs for medical devices.

Benefits

In addition, we support professional development and career growth, along with an attractive employee participation program.

We look forward to hearing from you by March 7th 2025.