Director of Quality Assurance

About the Role

We\’re seeking a senior Quality professional to take ownership of quality and regulatory excellence in a fast-growing medical device company. In this role, you\’ll ensure products meet the highest international standards, lead a talented QA/RA team, and play a key role in shaping processes that keep the business compliant and efficient as it grows.

Key Responsibilities

• Maintain, improve, and continuously develop the Quality Management System (ISO
• Support product development, manufacturing, and post-market activities to ensure full regulatory compliance.
• Lead internal and external audits, including Notified Body inspections and supplier audits.
• Develop and oversee risk management processes in line with ISO 14971.
• Lead and mentor a quality team, including performance management and professional development.
• Hire and expand the QA/RA team to support company growth.
• Collaborate with R&D, manufacturing, and regulatory teams to embed quality across the product lifecycle.
• Provide guidance on CAPA, change control, and corrective/preventive actions.
• Stay current on regulations, standards, and industry best practices.

Required Skills & Experience (Must-Have)

• 5–10+ years\‘ experience in Quality Assurance / Quality Management in the medical device industry.
• Strong knowledge of ISO 13485, ISO 14971, MDR 2017/745, and other relevant regulations.
• Proven experience leading audits and regulatory inspections.
• Leadership experience: managing, mentoring, and hiring QA/RA teams.
• Familiarity with risk management, CAPA, and supplier quality management.
• Ability to work independently, drive initiatives, and influence cross-functional teams.
• Strong communication, problem-solving, and collaboration skills.
• Fluent in English; German or French is a plus.

Why This Role is Exciting

• Work with innovative medical devices that make a real difference to patients.
• Significant autonomy and influence over quality strategy and systems.
• Join a collaborative, cross-functional team across Europe.
• Play a key role in building and shaping the QA/RA function in a growing organization.