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Hilo by Aktiia is a venture-backed medical device company (€96M+ raised) developing the world's only medically accurate, cuffless continuous blood pressure monitor. The technology is rooted in 18 years of research at CSEM and is CE-marked as a Class IIa medical device, now available in 12 countries.
As Senior Quality Engineer, you will own quality and manufacturing excellence across the product lifecycle. This is a hands-on senior role requiring independent judgment and cross-functional leadership in a fast-paced startup environment.
Key responsibilities include:
**Manufacturing Quality & Process Excellence**: Partner with manufacturing and contract manufacturing teams to lead 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 with effective root cause analysis and corrective actions.
**CAPA & Quality Systems Leadership**: Lead cross-functional investigations of quality issues. Own and drive CAPA processes with timely implementation. Ensure compliance with QMS requirements and regulatory standards. Monitor quality system performance and identify improvement areas.
**Product Quality & Release Management**: Review and approve LHRs, DHF deliverables, product releases, and engineering change orders. Ensure product documentation meets internal procedures and regulatory expectations. Support labeling reviews for compliance and usability.
**Supplier Quality Management**: Lead supplier management activities including audits, qualifications, and performance assessments for contract manufacturers. Drive improvements across the contract manufacturing network.
**Cross-Functional Collaboration**: Work with development, operations, manufacturing, and quality teams. Act as quality subject matter expert. Support internal and external audits. Coach teams on GMP and QMS requirements.
**Continuous Improvement**: Lead initiatives to improve product quality and operational efficiency. Promote quality culture and accountability. Identify process streamlining opportunities.
Required experience: 5–8+ years in quality engineering or manufacturing within medical devices. Hands-on experience with finished medical devices and contract manufacturing environments. Bachelor's degree in technical or scientific field. Solid knowledge of medical device regulations (MDR, ISO 13485, ISO 14971, FDA 21 CFR Part 820). Experience with risk management (FMEA) and QMS systems. Strong ownership, independent work capability, cross-functional leadership, problem-solving, and ability to manage multiple priorities. Proficiency with MS Office, eQMS systems, and modern digital tools.
