Sr. Quality Engineer - Manufacturing

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.

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

• 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

• 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

• 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

• 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

• 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

• 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

Requirements

• 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

• 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

• Strong ownership and ability to work independently with minimal supervision
• Proven ability to lead cross-functional initiatives and drive results
• Excellent problem-solving skills with a structured and analytical approach
• Ability to manage multiple priorities in a dynamic environment

• Proficiency with MS Teams, Word, Excel, and PowerPoint
• Experience with eQMS systems and modern digital tools (including AI-supported workflows)
• Strong project and time management skills

• Manufacturing and quality processes operate reliably, efficiently, and in full compliance
• Quality issues are resolved quickly and systematically, with strong root cause understanding
• Supplier quality is consistently high and continuously improving
• Cross-functional teams are aligned on quality standards and best practices
• Quality becomes a strong enabler of product excellence and scalability

What Makes You a Great Fit

At Hilo by Aktiia, our values guide how we work and grow:

• You focus on what drives real impact for product quality and patient safety
• You prioritise effectively and push for meaningful improvements
• You maintain a high bar for quality and execution

• You act with urgency while maintaining rigor and compliance
• You continuously improve processes and outcomes
• You adapt quickly to new challenges and evolving priorities

• You collaborate effectively across teams and functions
• You communicate clearly and provide constructive feedback
• You contribute to a culture of trust, accountability, and excellence

Benefits

• Hilo by Aktiia is becoming one of the most important med-tech companies, and you can be part of this exciting story
• Work on a mission that matters: transforming cardiovascular health at global scale
• Be part of a high-impact, fast-growing, and venture-backed scale-up company
• Collaborate with a diverse, passionate, and talented team
• Competitive compensation and equity program, and other benefits (depending on location)