Design Quality Assurance Engineer | Pharma (100% remote from Portugal or Spain)

We are looking for a Design Quality Assurance Specialist to join one of our international clients and support Quality Assurance activities across software and digital health product development and product care.

In this role, you will act as a Design Quality Assurance (DQA) specialist within cross-functional project teams, ensuring sustainable compliance throughout the product lifecycle. You will provide proactive quality support across Design Controls, Risk Management, documentation, audits, and process implementation, while collaborating closely with Quality, Regulatory, Software Engineering, and Business stakeholders in a highly regulated environment.

• Represent Design Quality Assurance within project teams, ensuring sustainable compliance across assigned projects and work areas.

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

• Participate in the generation, review, and approval of Design Control documentation and deliverables.

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

• Ensure that Design Quality issues that may impact the regulatory status of projects or products are identified, prioritized, and appropriately addressed.

• Support the effective implementation of Design Controls, development methodologies, and quality processes.

• Drive and support the effective implementation of Risk Management processes throughout the medical device product lifecycle.

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

• Support internal and external audits and inspections as a subject matter expert within the assigned area.

• Collaborate with Quality and Regulatory teams to gather, communicate, and share compliance-related information and ensure alignment across projects.

• Build and maintain effective relationships with key cross-functional stakeholders, promoting proactive communication and practical quality solutions.

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

• Support and act as a proxy for other Product Quality team members when required.

• Coach and support colleagues in developing their quality and compliance expertise.

• Maintain effective document management processes and ensure appropriate control of quality-related documentation.

SKILLS 🤹:

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

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

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

• Strong knowledge of Design Controls and quality processes applied to software and medical device development.

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

• Experience implementing and improving Design Controls, development methodologies, and related quality tools and processes.

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

• Experience with software development methodologies such as 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.

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

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

• Strong communication, negotiation, and influencing skills.

• Ability to navigate complex situations, manage shifting priorities, and work effectively across multidisciplinary teams.

• Fluent English, with the ability to communicate clearly and precisely in complex and international environments.

NICE TO HAVE:

• Experience working in international and multicultural environments.

• Experience supporting internal and external regulatory audits or inspections.

• Experience working with digital health or software-based medical products throughout their complete lifecycle.

• Experience developing or improving quality capabilities, processes, and supporting tools.

• Experience coaching colleagues or acting as a subject matter expert within Quality Assurance.

• Strong stakeholder management and conflict resolution skills.

• Proactive mindset with strong ownership, resilience, and accountability.

• Ability to adapt effectively to changing priorities and complex project environments.

• Experience with document and data management systems supporting regulated product development.

• Familiarity with cybersecurity risk management within software-based medical devices.

SCHEDULE 🕘:

• 08/09h -17/18h from Monday to Friday (flexible)

• 100% remote position

CONDITIONS 🌱:

• Salary package based on your profile. 

• Permanent Contract.

• Flexible Retribution Program (medical insurance, public transport ticket and childcare check)

• Discounts on gym network (Wellhub)

• Learning & Development.

Our goal is that you are well in every way!