Senior Design Quality Assurance Engineer – Pharma

This is a fully remote position, open to applicants in Portugal, +1 more country.

📋 Description

• Provide strategic leadership in quality for digital health products and GxP-compliant software platforms throughout the entire product lifecycle.

• Ensure the implementation and ongoing maintenance of design controls, risk management, and quality processes within software development settings.

• Serve as the main quality liaison between software development, digital infrastructure, data analytics, and various cross-functional stakeholders.

• Assist teams in meeting regulatory compliance standards for medical devices, IVDs, and digital health solutions.

• Act as a Subject Matter Expert during design reviews, milestone evaluations, audits, and regulatory inspections.

• Manage documentation, change control, product release, and complaint handling systems effectively.

• Provide quality oversight for activities related to agile development.

• Aid in the preparation and upkeep of validation and compliance documentation, including CSV activities.

• Identify quality-related risks and implement practical, compliant solutions.

• Mentor and support teams to enhance quality culture, capability enhancement, and knowledge sharing.

⛳️ Requirements

• Bachelor’s or advanced degree in Science, Software Engineering, or a related field.

• Over 5 years of experience in Quality Assurance and Computerized System Validation (CSV) within regulated sectors like digital health, medical devices, IVD, or pharmaceuticals.

• Demonstrated experience in quality assurance within software engineering.

• Familiarity with design controls and risk management practices.

• Experience with Computer System Validation (CSV) for GxP-compliant digital health platforms.

• In-depth knowledge of FDA QSR, ISO 13485, ISO 14971, IEC 62304, IEC 82304, IEC 62366, along with relevant cybersecurity standards.

• Comprehensive technical understanding of SDLC, systems engineering principles, cloud and SaaS platforms, system integrations, data analytics, and data flows.

• Practical experience in agile development methodologies such as Scrum, Kanban, or SAFe.

• Excellent skills in communication, influencing, collaboration, judgment, negotiation, decision-making, conflict resolution, and relationship management.

• Proficiency in English.

• Ability to work Monday to Friday, from 08/09h to 17/18h, with flexibility.

🏝️ Benefits

• Permanent Contract.

• Opportunities for Learning & Development.

• Flexible schedule.

• Fully remote work.

• Occasional business travel may be necessary.