Project Quality Engineer- Cybersecurity Process Specialist

SHS AT QT (Advanced Therapies Quality Regulatory Team) is a global organization focused on ensuring product quality, regulatory compliance, and patient safety across the product lifecycle. It supports innovation by integrating Quality Engineering, Risk Management, Reliability Engineering, and regulatory expertise into product development. The team drives digitalization, AI adoption, and continuous process improvement to enhance efficiency and compliance. SHS AT QT aims to deliver high-quality healthcare solutions faster, enabling better outcomes for patients, customers, and healthcare providers worldwide.

Responsibilities

• Analyzing, collecting data, and providing accurate, documented information about the status of quality
• Verifying the correctness of quality related development results in compliance with the Quality Management Plan authorize their release for medical devices
• Validation of compliance to basic requirements, e.g. ISO standards and regulations like Medical Device Regulation (European Union Regulation), Quality system regulation (US FDA)
• Assessment of completeness of Design history file and Device master records- Participate in reviews as per QMS, external and internal audits
• Apply technical understanding of cybersecurity concepts to support project teams.
• Identify gaps in existing cybersecurity processes and drive improvements.
• Verify that cybersecurity deliverables are complete and compliant for product launches, regulatory submissions, audits, and technical file updates

Experienced in:

• Product risk management non-product software validation processes for medical devices
• Creation and maintenance of technical file/summary technical documentation (STED)
• Medical device development (including SW) and Software engineering best practices
• Agile methods / TIR45
• Experienced in end-to-end (E2E) cybersecurity process handling across the product lifecycle
• Reviews and interprets cybersecurity findings raised by various regulatory bodies and supports the related remediation activities
• Supports the maintenance of post-market cybersecurity documentation to keep products audit-ready and prepared for regulatory review

Knowledge :

• Implementing ISO 9001, 13485, ISO 14971, IEC 62304 IEC 82304 within projects
• Compliance of requirements from MDR, QSR
• Non-regulated software like Apps for Apple / Android
• Cybersecurity (ISO 80001, SW Vulnerability Management), Information security (ISO 27001)
• Strong knowledge of product cybersecurity processes and good technical understanding of healthcare/medical device cybersecurity requirements
• Knowledge of cybersecurity expectations from various regulatory bodies (FDA,EU Korea etc), including FDA premarket postmarket cybersecurity guidance,
• Knowledge of EU MDR requirements (MDCG 2019-16, Annex I security-related essential requirements), IEC 81001-5-1 (health software security), and IMDRF cybersecurity principles - at a process/regulatory-expectation level

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