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Clinical and digital devices quality lead pharmaceuticals [f/m/x]

Braine-l'Alleud
Amaris Consulting
De 100 000 € à 125 000 € par an
Publiée le Publiée il y a 9 h
Description de l'offre

Mission Overview
Shape the quality framework for cutting‑edge clinical digital devices in a fast‑paced medical technology environment. This role bridges biomedical engineering expertise with pragmatic quality assurance, ensuring innovative digital health solutions meet the highest standards while maintaining speed to market.

Your Impact
Establish and lead quality processes for digital clinical devices – from concept through deployment – balancing regulatory rigor with innovation velocity in an evolving startup‑like environment.

Core Responsibilities
Quality Strategy & Execution

Digital QA Leadership: Design and implement quality frameworks specifically for digital health devices and software

Risk‑Based Approach: Prioritize quality activities based on actual patient safety and regulatory impact

Technical Translation: Convert complex technical requirements into clear, actionable guidance for cross‑functional teams

End‑to‑End Quality: Oversee device lifecycle quality from development through clinical deployment

Collaboration & Communication

Cross‑functional Leadership: Guide small, agile teams through quality decision‑making processes

Stakeholder Communication: Present technical quality concepts to non‑technical audiences including clinical and business teams

Solution Architecture: Identify quality risks and propose practical, innovative solutions

Your Profile
Professional Foundation

Educational Background: Degree in biomedical engineering, engineering, life sciences, or software‑related fields

Experience Level: 3‑5 years in quality assurance within medical technology or digital health

Digital Mindset: Strong understanding of software development and digital device technologies

Fluent in English

Core Competencies

Pragmatic Approach: Focus on what truly matters rather than perfectionism

Structured Thinking: Organize complex information into clear, prioritized action plans

Synthesis Skills: Distill technical complexity into concise, understandable insights

Ownership Mentality: Take full responsibility for quality outcomes within a lean team structure

Work Style

Adaptability: Thrive in fast‑changing, imperfect environments

Leadership: Comfortable leading quality initiatives without extensive hierarchy

Communication: Exceptional ability to explain technical concepts to diverse audiences

Full remote possible

Environment & Culture

Innovation Focus: Work with cutting‑edge digital health technologies

Agile Structure: Small, evolving teams with minimal bureaucracy

Impact Opportunity: Shape quality processes from the ground up

Growth Potential: Expand expertise across clinical, digital, and regulatory domains

Why joining us?
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.

Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.

International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.

Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

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