Hedera Dx

Founded in Switzerland in 2021, Hedera Dx is bringing access to advanced cancer care to the next billion people worldwide. This requires building highly sophisticated technology solutions based on molecular biology and artificial intelligence to serve patients and healthcare professionals.

We bring tumor profiling, the use of liquid biopsies, and real-world data insights to health systems globally. Our work leads to improved patient experiences and outcomes now, while advancing the development of breakthrough precision oncology therapies.

Our team

We are currently a team of 21 people from diverse backgrounds working across Europe, and we’re looking for a longstanding team member to join us. Here’s what we offer:

• A relaxed atmosphere that allows for focus and getting things done.
• A people-first, purpose-driven culture that encourages ambition and inclusivity.
• Competitive salary plus options.
• Work location: Helsinki office or fully remote.

The QA&RA Manager Role

As a QA&RA Manager, you’ll lead quality management practices, work closely with cross-functional teams to implement quality standards, and oversee regulatory affairs. This is an exciting opportunity to make a significant impact on cancer care and grow within a team dedicated to healthcare innovation.

Key Responsibilities:

Quality Management

• Develop and maintain a Quality Management System (QMS) that aligns with industry requirements and best practices.
• Maintain a robust risk management practice to identify, assess, and mitigate potential risks.
• Lead initiatives to identify and implement process improvements across Hedera Dx.
• Oversee document control processes to ensure accuracy and accessibility.

Regulatory Affairs

• Stay informed on relevant regulations and standards, including IVDR, ISO 13485, ISO 27001, and GDPR, ensuring ongoing compliance.
• Manage regulatory submissions and oversee post-market surveillance activities.
• Assume the role of Person Responsible for Regulatory Compliance (PRRC).

Collaboration & Training

• Coordinate and manage internal and external audits to ensure adherence to quality standards.
• Collaborate with teams to develop and deliver quality-related training programs.
• Work closely with suppliers to develop and implement supplier management practices.
• Collaborate with R&D to manage device roadmaps and design controls.
• Partner with Operations on product configuration and documentation.

Qualifications:

• Bachelor’s or Master’s degree in a scientific or engineering field relevant to medical devices
• Working experience in a quality management role within medical devices
• Understanding of relevant regulations and standards, including IVDR and ISO 13485
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across diverse teams
• Proven ability to analyze complex issues, identify root causes, and come up with solutions

Recruitment process

Our recruitment process values transparency, curiosity, and engagement. Here’s what to expect at each stage:

1. We’ll review your profile and get back to you if it’s a potential match (or let you know if it’s not).
2. We’ll invite you to a remote interview to learn more about each other and discuss Hedera Dx.
3. You’ll participate in a session to demonstrate your skills and experience hands-on.
4. After getting to know you better, we’ll discuss practicalities and your role in our team.
5. If we’re both aligned and excited, we’ll share a job offer for you to join Hedera Dx.

Ready to join a mission-driven team in healthcare innovation? Apply now and make a difference in cancer care worldwide.