Sr. Quality Engineer - Manufacturing

Hilobyaktiia seeks a Senior Quality Engineer to strengthen quality and manufacturing excellence for medical devices. The role involves ensuring compliance, reliability, and continuous improvement across product lifecycle and contract manufacturing, with a hybrid work model in Neuchâtel, CH.

This role is designed to enhance quality and manufacturing excellence at Hilobyaktiia by overseeing quality processes across manufacturing, supplier management, and product lifecycle. It requires collaboration with development, operations, and manufacturing teams to ensure products meet regulatory and quality standards, while driving continuous improvement in a fast-paced startup environment.

Responsibilities

• Collaborate with manufacturing and contract manufacturers to lead quality engineering efforts
• Oversee process validations (IQ, OQ, PQ) and test method validations
• Implement and maintain robust manufacturing controls and continuous improvement initiatives
• Investigate and resolve non-conformances through root cause analysis and corrective actions
• Lead cross-functional teams in addressing quality issues and driving resolution
• Manage CAPA processes to ensure timely and effective implementation
• Maintain compliance with QMS and regulatory standards throughout product lifecycle
• Monitor quality system performance and identify improvement opportunities
• Review and approve LHRs, DHF deliverables, product releases, and engineering change orders
• Ensure product documentation meets internal and regulatory requirements
• Support labeling reviews for compliance with standards and usability
• Lead supplier management, including audits, qualifications, and performance evaluations for contract manufacturers
• Work with contract manufacturers to maintain consistent quality standards
• Drive quality improvements across the contract manufacturing network
• Coordinate with development, operations, manufacturing, and quality teams
• Serve as a quality subject matter expert across projects
• Support internal and external audits to ensure successful outcomes
• Coach internal and external teams on GMP and QMS requirements
• Lead initiatives to improve product quality and operational efficiency
• Foster a culture of quality, accountability, and continuous improvement
• Identify opportunities to streamline processes and enhance scalability

Requirements

• 5–8+ years of experience in quality engineering or manufacturing within the medical device industry
• Direct experience with finished medical devices
• Proven experience in contract manufacturing environments
• Bachelor’s degree in a technical or scientific field
• Strong understanding of medical device regulations and standards (MDR, ISO 13485, ISO 14971, FDA 21 CFR Part 820)
• Experience with risk management, including process and design FMEA
• Familiarity with QMS systems and audit procedures
• Strong ownership and ability to work independently with minimal supervision
• Track record of leading cross-functional initiatives and delivering results
• Excellent problem-solving skills with a structured, analytical mindset
• Ability to manage multiple priorities in a dynamic environment
• Proficiency in MS Teams, Word, Excel, and PowerPoint
• Experience with eQMS systems and modern digital tools, including AI-supported workflows
• Strong project and time management skills

What the company offers

• Competitive compensation and equity program
• Opportunity to contribute to a mission-driven effort: transforming cardiovascular health globally
• Join a high-impact, fast-growing, venture-backed scale-up
• Work alongside a diverse, passionate, and talented team

About the company

Hilobyaktiia is a hybrid/remote-first company headquartered in Neuchâtel, Switzerland, focused on transforming cardiovascular health. The company is venture-backed, having raised over $96M, and its technology is based on 18 years of research at CSEM. Their solution is CE Marked as a Class IIa medical device and available in 12 countries. The company is driven by a mission to prevent lives lost or damaged by high blood pressure, and values innovation, speed, learning, and teamwork.

• Hybrid/remote-first work environment with headquarters in Neuchâtel, Switzerland
• Driven by passion for innovation and impact
• Mission to make cardiovascular health accessible through technology
• Venture-backed with over $96M in funding from European and U.S. investors
• Technology rooted in 18 years of research at CSEM
• Solution is CE Marked as a Class IIa medical device and available in 12 countries
• Values moving fast, learning, refining, and being team-first