Design Quality Assurance Engineer – Pharma

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

📋 Description

• Act as the representative for Design Quality Assurance within project teams, ensuring consistent compliance across designated projects and work areas.

• Offer proactive Design Control quality support throughout product development and care activities.

• Engage in the creation, review, and approval of Design Control documentation and deliverables.

• Assist in the planning and execution of Design Control deliverables, project milestones, and design reviews.

• Identify, prioritize, and effectively address Design Quality issues that could influence regulatory status.

• Aid in the implementation of Design Controls, development methodologies, and quality processes.

• Drive and support Risk Management processes throughout the lifecycle of medical device products.

• Provide quality guidance and educate business and project teams on quality topics, compliance requirements, and best practices.

• Support internal and external audits and inspections as a subject matter expert.

• Collaborate with Quality and Regulatory teams to share compliance-related information and ensure project alignment.

• Establish and maintain relationships with cross-functional stakeholders.

• Contribute to continuous improvement and innovative solutions to quality and compliance challenges.

• Provide support and act as a substitute for other Product Quality team members when necessary.

• Mentor colleagues in quality and compliance expertise.

• Oversee document management processes and control quality-related documentation.

⛳️ Requirements

• Bachelor's or advanced degree in Science, Software Engineering, or a related discipline.

• Over 5 years of experience in Quality Assurance within the Digital Health sector or a related field.

• Demonstrated experience in Software Quality Engineering or Quality Assurance within regulated industries such as Medical Devices, In-Vitro Diagnostics, Pharma, or Digital Health.

• Strong understanding of Design Controls and quality processes related to software and medical device development.

• Technical knowledge of software, systems development, and software development tools.

• Experience in implementing and enhancing Design Controls, development methodologies, and associated quality tools and processes.

• Proven capability in implementing and maintaining Risk Management processes throughout the medical device product lifecycle.

• Familiarity with software development methodologies like SAFe, Scrum, Kanban, or similar Agile frameworks.

• Knowledge of digital health standards and regulations, including FDA QSR, ISO 13485, ISO 14971, IEC 62304, IEC 82304, and IEC 62366.

• Understanding of cybersecurity standards applicable to medical devices and digital health products.

• Experience with quality systems and tools that support document management, data and change control, product release, and complaint handling.

• Strong communication, negotiation, and influencing abilities.

• Ability to navigate complex situations, manage changing priorities, and collaborate effectively across multidisciplinary teams.

• Fluent in English, capable of communicating clearly and accurately in complex and international settings.

• Nice to have: experience in international and multicultural environments, supporting internal and external regulatory audits or inspections, working with digital health or software-based medical products throughout their entire lifecycle, developing or improving quality capabilities/processes/tools, coaching colleagues or serving as a subject matter expert, stakeholder management and conflict resolution, document/data management systems, and cybersecurity risk management.

🏝️ Benefits

• Permanent Contract.

• Flexible Retribution Program (medical insurance, public transport tickets, and childcare vouchers).

• Discounts on gym network (Wellhub).

• Learning & Development opportunities.

• Flexible schedule.

• 100% remote position.