Senior Design Quality Assurance Engineer – Pharma

Ambit Iberia

. Provide strategic quality leadership for digital health products and GxP-relevant software platforms throughout the full product lifecycle .

Posted 11/10/2026full-timeRemote • Portugal, SpainSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Assurance and Computerized System Validation (CSV) within regulated environments, with a strong focus on digital health products and GxP-relevant software platforms. Proven ability to lead quality initiatives, ensure regulatory compliance, and foster a quality culture across cross-functional teams.

Highest-signal resume keywords

Quality AssuranceComputerized System Validation (CSV)Regulatory ComplianceDesign ControlsRisk Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality LeadershipSoftware Engineering Quality AssuranceAgile DevelopmentDesign ControlsRisk ManagementComputer System Validation (CSV)FDA QSRISO 13485ISO 14971IEC 62304

Soft Skills

CommunicationCollaborationInfluencingDecision-MakingConflict Resolution

Tools & Technologies

Digital Health PlatformsCloud PlatformsSaaS PlatformsData AnalyticsSystems Engineering

Industry Keywords

GxPMedical DevicesIVDPharmaceuticalsCybersecurity Requirements

Tech Stack

Tools & technologies

CloudCyber SecuritySDLC

About the role

Key responsibilities & impact

Provide strategic quality leadership for digital health products and GxP-relevant software platforms throughout the full product lifecycle
Ensure implementation and maintenance of design controls, risk management, and quality processes in software development environments
Act as the primary quality interface between software development, digital infrastructure, data and analytics, and other cross-functional stakeholders
Support 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 documentation management, change control, product release, and complaint handling systems
Provide quality oversight for agile development activities
Support preparation and maintenance of validation and compliance documentation, including CSV activities
Identify quality risks and drive pragmatic, compliant solutions
Coach and support teams to strengthen quality culture, capability development, and knowledge sharing

Requirements

What you’ll need

Bachelor’s or advanced degree in Science, Software Engineering, or a related discipline
5+ years of experience in Quality Assurance and Computerized System Validation (CSV) within regulated environments such as digital health, medical devices, IVD, or pharmaceuticals
Proven experience in software engineering quality assurance
Experience with design controls and risk management
Experience with Computer System Validation (CSV) for GxP-relevant digital health platforms
Strong knowledge of FDA QSR, ISO 13485, ISO 14971, IEC 62304, IEC 82304, IEC 62366, and relevant cybersecurity requirements
Broad technical understanding of SDLC, systems engineering principles, cloud and SaaS platforms, system integrations, data analytics, and data flows
Practical experience in agile development environments such as Scrum, Kanban, or SAFe
Excellent communication, influencing, collaboration, judgment, negotiation, decision-making, conflict resolution, and relationship-building skills
Fluency in English
Ability to work Monday to Friday, 08/09h–17/18h, with flexibility

Benefits

Comp & perks

Permanent Contract
Learning & Development
Flexible schedule
100% remote work
Some business travel may be required