Senior Quality Engineer — MedTech Design Controls Leader

Hilo by Aktiia; Neuenburg; Vor Ort; CHF 110.000 - 160.000; Vollzeit

Zusammenfassung

Hilo by Aktiia seeks a Senior Quality Engineer to lead design controls, risk management, and regulatory compliance across the medical device product lifecycle. You will partner with engineering, clinical, regulatory, and product teams to ensure inspection-ready documentation and robust quality systems.

The role requires independent work, prioritization, and influencing cross-functional teams in a fast-paced development environment. Remote-friendly with global regulatory coordination.”

Qualifikationen

• Bachelor’s degree in Engineering, Life Sciences, or technical field.
• 5–8 years in Quality Engineering, Design Assurance, or Product Development Quality in medical devices.
• Strong knowledge of ISO 13485, FDA QSR, EU MDR, and ISO 14971.

Aufgaben

• Provide Quality leadership across the product development lifecycle, including design controls and risk management.
• Ensure compliance with design control, risk management, and quality system requirements for new and sustaining projects.
• Lead Design Assurance activities: planning, reviews, verification, validation, transfer, and change management.

Kenntnisse

Design Controls

Risk Management

Quality System

Regulatory Affairs

Cross-functional Leadership

Project Management

Communication

eQMS familiarity

PLM systems

Problem solving

Ausbildung

Bachelor’s degree in Engineering

Advanced degree a plus

Tools

eQMS

PLM systems

Microsoft Office

Jobbeschreibung

Hilo by Aktiia seeks a Senior Quality Engineer to lead design controls, risk management, and regulatory compliance across the medical device product lifecycle. You will partner with engineering, clinical, regulatory, and product teams to ensure inspection-ready documentation and robust quality systems.

The role requires independent work, prioritization, and influencing cross-functional teams in a fast-paced development environment. Remote-friendly with global regulatory coordination.”