Quality System Engineer with DHT Technical Capabilities

Elan AG seeks a Senior Quality Systems Engineer Consultant to manage DHT technical capabilities, regulatory assessments, and vendor quality assurance on-site in Basel.

The company is looking for a consultant to provide specialized technical support for Digital Health Technologies (DHTs). This role focuses on regulatory evaluations, documentation integrity, change control, and knowledge transfer to ensure high-quality standards across clinical trial partnerships.

Responsibilities

• Act as the main technical liaison with third-party device manufacturers, addressing design controls, risk management, and contractual agreements.
• Maintain the technical documentation asset list and perform detailed reviews of manufacturer data to prepare submission materials.
• Collaborate with Product Management and Design leaders to characterize DHTs and contribute to internal regulatory assessments.
• Evaluate the impact of study-related changes on technical accuracy, documentation, and overall study integrity.
• Partner with Quality, Product Management, and Procurement teams to assess vendor capabilities and identify technical gaps.
• Oversee manufacturer deliverables and lead remediation efforts to update documentation as needed.
• Review Design History Files (DHFs) and product development records from external DHT suppliers.
• Perform Risk Management and Computerized System Validation (CSV) for non-medical device products, following global SOPs.
• Ensure all activities comply with Roche’s internal quality standards and global standard operating procedures.
• Draft or assist clinical teams with technical documentation and risk management plans to meet ISO standards and Health Authority requirements.
• Support training initiatives to upskill team members on medical device development and quality documentation.

Requirements

• Bachelor’s degree in Computer Science, Software Engineering, Informatics, Biomedical Engineering, or a related field, or equivalent practical experience; Master’s or advanced degree preferred.
• Minimum of seven years of experience in the medical device or pharmaceutical sector.
• Deep expertise in applying ISO 13485, ISO 14971, IEC 62304, IEC 62304, IEC 60601-1, 21 CFR 820, 21 CFR Part 11, Annex 11, and GAMP 5.
• Experience conducting clinical investigations compliant with ISO 14155.
• Familiarity with ISO/IEC 27001 and cybersecurity principles in medical device development.
• Certification as an ISTQB Test Manager with strong skills in Computerized System Validation (CSV) and software quality assurance.
• Working knowledge of GCP, GxP, and GMP practices.
• Proven ability to interact with the FDA’s Center for Devices and Radiological Health, EU Health Authorities under MDR, and Notified Bodies.
• Demonstrated success working in global, matrixed environments.
• Fluent proficiency in English.

Nice to have

• Experience with cybersecurity standards relevant to product development.
• Previous experience leading training on ISO 14971 or IEC 62304/SDLC.
• Prior familiarity with working within the Roche Group.

What the company offers

• Chance to work at a leading global pharmaceutical organization.
• Access to a modern campus featuring green spaces and collaborative meeting areas.
• Convenient central location in Basel.
• A diverse and varied job profile.
• Opportunities for further training via temptraining.
• Collaboration within a dynamic and motivated team.

About the company

The organization partners with numerous third-party manufacturers of Digital Health Technologies to address diverse measurement requirements across clinical trials, relying on rigorous quality systems and technical expertise.

• Collaborative environment focused on meeting clinical trial measurement needs.
• Commitment to high-quality standards and regulatory compliance.
• Supportive culture for knowledge transfer and team upskilling.