Remote Senior Design QA Engineer, Pharma

Ambit Iberia; Sant Cugat del Vallès; Remote; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Remote work

Learning & Development

Permanent Contract

Job summary

Ambit Iberia is seeking a Senior Design Quality Assurance Expert to lead quality and regulatory activities for digital health and GxP-relevant software platforms. You will drive design controls, risk management, CSV, and quality processes across the full product lifecycle.

You will collaborate with software, data analytics, and infrastructure teams in a fast-paced, regulatory environment. Fluency in English is essential, and prior experience with FDA QSR, ISO 13485, ISO 14971, and IEC standards

Qualifications

• Bachelor's or advanced degree in Science, Software Engineering, or related discipline.
• 5+ years of QA and CSV in regulated environments (digital health, medical devices, IVD, pharma).
• Fluency in English.

Responsibilities

• Provide strategic quality leadership for digital health products throughout the full product lifecycle.
• Ensure effective design controls, risk management, and quality processes in software development environments.
• Act as the primary quality interface between software development, digital infrastructure, data & analytics, and other cross-functional stakeholders.
• Support and guide teams on regulatory compliance requirements for medical devices, IVDs, and digital health solutions.
• Contribute as a Subject Matter Expert to design reviews, milestone reviews, audits, and regulatory inspections.
• Oversee and support key quality processes, including documentation management, change control, product release, and complaint handling systems.
• Provide quality oversight for agile development activities, ensuring compliance without compromising delivery speed or innovation.
• Support the preparation and maintenance of validation and CSV documentation.

Skills

Quality Assurance

CSV

Regulatory

Agile

SDLC

Cross-functional

Education

Bachelor's or advanced degree in Science/Software Engineering

Job description

Ambit Iberia is seeking a Senior Design Quality Assurance Expert to lead quality and regulatory activities for digital health and GxP-relevant software platforms. You will drive design controls, risk management, CSV, and quality processes across the full product lifecycle.

You will collaborate with software, data analytics, and infrastructure teams in a fast-paced, regulatory environment. Fluency in English is essential, and prior experience with FDA QSR, ISO 13485, ISO 14971, and IEC standards