Senior Quality Engineer

About Hilo by Aktiia

High blood pressure is the world’s most common disease, causing 18M deaths each year. At Hilo by Aktiia, our vision is a world where no lives are lost or damaged from the effects of high blood pressure. Our mission is to make this a reality by developing tech to help people control their blood pressure.

We are a venture-backed scale-up company, having raised over $96M from investors in Europe and the United States. Our technology - rooted in 18 years of research at the Swiss Center for Electronics and Microtechnology (CSEM) - is the world’s only medically accurate, continuous blood pressure monitor that is cuffless in daily life in the consumer space. Validated through extensive clinical trials and CE Marked as a Class IIa medical device, our solution is now available in 12 countries. We are a hybrid/remote-first company, with Headquarters in Neuchâtel, Switzerland, united by our passion for impact and innovation.

Role Overview

We are looking for a highly motivated Senior Quality Engineer to strengthen our quality and manufacturing excellence at Hilo by Aktiia. In this role, you will play a critical part in ensuring the reliability, compliance, and continuous improvement of our medical device products across their full lifecycle.

This is a senior, hands‑on role where you will take ownership of quality processes across manufacturing, supplier management, and product lifecycle activities. You will work cross-functionally with development, operations, and manufacturing teams to ensure that all products meet the highest standards of quality and regulatory compliance.

You will act as a key driver of quality culture within the organization leading investigations, improving processes, and ensuring that both internal teams and external partners operate in alignment with medical device regulations and best practices.

This role requires a proactive mindset, strong technical judgment, and the ability to operate independently while adapting to evolving priorities in a fast-paced startup environment.

Core Responsibilities

Manufacturing Quality Process Excellence

• Partner with manufacturing teams and contract manufacturers to lead and support quality engineering activities
• Drive and support process validations (IQ, OQ, PQ) and test method validations
• Ensure robust manufacturing process controls and continuous improvement initiatives
• Resolve non-conformances and ensure effective root cause analysis and corrective actions

CAPA Quality Systems Leadership

• Lead cross-functional efforts to investigate and resolve quality issues
• Own and drive CAPA processes, ensuring timely and effective implementation
• Ensure ongoing compliance with QMS requirements and regulatory standards
• Monitor quality system performance and identify areas for improvement

Product Quality Release Management

• Review and approve LHRs, DHF deliverables, product releases, and engineering change orders
• Ensure all product documentation meets internal procedures and regulatory expectations
• Support labeling reviews to ensure compliance with applicable standards and usability requirements

Supplier Quality Management

• Lead supplier management activities, including audits, qualifications, and performance assessments for contract manufacturers
• Collaborate closely with contract manufacturers to ensure consistent quality standards
• Drive improvements across the contract manufacturing supplier network to enhance product quality and reliability

Cross-Functional Collaboration

• Work closely with development, operations, manufacturing, and quality teams
• Act as a quality subject matter expert across projects and initiatives
• Support internal and external audits, ensuring readiness and successful outcomes
• Coach internal teams and external partners on GMP and QMS requirements

Continuous Improvement Quality Culture

• Lead initiatives to improve product quality and operational efficiency
• Promote a strong culture of quality, accountability, and continuous improvement
• Identify opportunities to streamline processes and increase scalability

Experience

• 5–8+ years of experience in quality engineering or manufacturing within the medical device industry
• Hands‑on experience working with finished medical devices
• Strong experience with contract manufacturing environments
• Bachelor’s degree in a technical or scientific field

Quality Regulatory Expertise

• Solid knowledge of medical device regulations and standards (MDR, ISO 13485, ISO 14971, FDA 21 CFR Part 820)
• Experience with risk management processes (e.g., process and design FMEA)
• Familiarity with QMS systems and audit processes

Leadership Mindset

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