Senior Design Quality Assurance Expert - Remote

Overview

We are looking for a Senior Design Quality Assurance Expert for one of our clients in the Digital Health / Life Sciences Sector.

In Short

• Provides strategic quality leadership within cross-functional teams.
• Ensures compliance with global regulatory requirements.
• Applies design controls and risk management methodologies.
• Acts as a key bridge between software development and regulatory teams.
• Supports documentation management and product release activities.
• Serves as a subject matter expert during audits and inspections.
• Identifies compliance risks and proposes mitigation strategies.
• Builds strong relationships with internal and external partners.
• Supports innovation in digital health solutions.
• 100% remote position with flexible schedule.

Requirements

• Bachelor’s or Master’s degree in Science, Software Engineering, or related discipline.
• 5+ years of experience in Quality Assurance within regulated environments.
• Strong expertise in software quality engineering.
• Proven experience with risk management methodologies (ISO 14971).
• Solid knowledge of global regulatory standards (FDA QSR, ISO 13485).
• Experience in agile development environments (Scrum, Kanban).
• Fluency in English with strong communication skills.

Benefits

• Salary package based on your profile.
• Permanent Contract.
• Learning & Development opportunities.