Connected Health Quality Expert (all genders)

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your role:

Be the quality representative for digital health projects, software as a medical device, including web-based, cloud solutions, and mobile applications, connected devices and medical devices in the field of drug delivery systems for multiple therapeutical area:

• Ensure compliance to design control process
• Participate to the continuous improvement of quality processes and procedures
• Review and approve project deliverables (internal and from suppliers) and agreements
• Support design reviews, approve/disapprove move to next phase
• Identify applicable quality, regulatory, data privacy and cybersecurity requirements, guiding internal and external parties for their implementation.
• Participate to the qualification of suppliers through audits and assessments
• Compile technical documentation
• Act as quality project manager to ensure proactive identification and resolution of problems through adequate actions, communication or escalation when needed.
• Collaborate with different functions and stakeholders (engineering, procurement, supply chain, packaging and labeling, legal, regulatory, operations, suppliers) with the objective of reaching clarity and minimize gaps.
• Participate to audits from authorities.
• Support regulatory submissions worldwide

Who you are:

• Master, or PhD degree in computer science or similar
• Precise, rigorous, and detail oriented
• Team player, ability to collaborate with multidisciplinary teams located worldwide
• Global, international orientation
• Confident personality able to take independent decisions with leading attitude when required
• Able to handle complexity and to simplify and summarize complicated topics
• Supportive, keen to promote quality through example and continuous support across different areas
• Knowledge of medical device industry standards such as ISO 13485, 21 CFR 820, IEC 62304, IEC 82304, ISO 14971, IEC 60601-1, IEC 81001-5-1, and FDA software guidelines
• Fluent in English
• At least 2 years of experience with software solutions design and development or electromechanical medical devices design and development.
• At least 2 years of experience in quality systems for regulated industry (preferable medical devices / pharma)
• Experience with embedded software development or cloud solution is a plus
• Experience with data privacy and/or cybersecurity is a plus
• Experience with medical device clinical evaluation is a plus

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!