Remote Senior Quality Engineer - Med Devices

Hilo By Aktiia; Österreich; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

Hilo by Aktiia, based in Neuchâtel, Switzerland, is seeking a Senior Quality Engineer to lead Design Controls, Risk Management, and Quality System activities for our cuffless血 pressure monitor in a remote-first environment.

You will partner with Engineering, Regulatory, Clinical, and QA teams to ensure DHFs, risk assessments, and regulatory submissions are complete and compliant, while driving continuous improvement in a fast-paced med‑tech setting.

Qualifikationen

• 5–8 years of experience in Quality Engineering, Design Assurance, or Product Development Quality in the medical device industry.

Aufgaben

• Lead Design Controls, Risk Management, and Quality System activities across the product development lifecycle.
• Collaborate with Engineering, Product Management, Clinical, Regulatory Affairs, and Project Management to support new product development and changes.
• Ensure DHFs, technical documentation, and design records are complete, compliant, and inspection-ready.
• Support CAPA, nonconformance investigations, audits, and continuous improvement initiatives.

Kenntnisse

Design Controls

Risk Management

Regulatory knowledge

Documentation

Quality Systems

Cross-functional leadership

Ausbildung

Bachelor's degree in Engineering

Advanced degree a plus

Tools

eQMS

PLM systems

Jobbeschreibung

Hilo by Aktiia, based in Neuchâtel, Switzerland, is seeking a Senior Quality Engineer to lead Design Controls, Risk Management, and Quality System activities for our cuffless血 pressure monitor in a remote-first environment.

You will partner with Engineering, Regulatory, Clinical, and QA teams to ensure DHFs, risk assessments, and regulatory submissions are complete and compliant, while driving continuous improvement in a fast-paced med‑tech setting.