Quality System Engineer with DHT Technical Capabilities

Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-term client, F. Hoffmann-La Roche AG in Basel, we are looking for a

Background:

Digital Health Technologies (DHTs), including those with medical device capabilities, are essential for enhancing patient value and supporting data-driven clinical decision-making. To meet the diverse measurement needs across clinical trials, the organization collaborates with multiple third-party DHT manufacturers. While DHTs provide critical evidence, their implementation requires specialized technical expertise and introduces additional complexity to study delivery.

A limited number of internal experts currently possess the required DHT Technical Capabilities to manage regulatory identity assessments, technical documentation, manufacturer data reviews, and change control activities. This capacity gap creates bottlenecks that may delay study initiation and impact successful DHT integration.

The organization is seeking a Quality Systems Engineer Consultant to provide additional DHT Technical Capabilities, supporting regulatory assessments, documentation reviews, change control, remediation activities, and knowledge transfer. The consultant will help strengthen capabilities, ensure compliance, and enable effective integration of DHTs across Roche Pharma’s clinical study portfolio.

The assignment is based within the Digital Endpoints and Patient Solutions (DEPCS) group’s Product Management and Design team and supports the broader product development portfolio.

Tasks & Responsibilities:

• Serving as the single point of contact: for technical conversations with third party device manufacturers regarding design controls, risk management, and agreements. Act as the Subject Matter Expert (SME) on device requirements and technical nuances; also ensure these elements are appropriately integrated into study protocols and documentation.
• Compile and maintain the "Asset List" (Technical Documentation), perform technical reviews of manufacturer data, and author or review technical content for submission documents.
• Digital & Regulatory Identity: Co-lead the regulatory characterization of DHTs with the Product Management & Design Leaders, which involves providing input into Roche’s internal Device Regulatory Assessment and supporting updates.
• Change Control: Act as the intake point and primary assessor for changes during a study, rigorously evaluating the impact on technical accuracy, documentation, and overall study integrity. Work will also help inform third party manufacturers of updates needed in their design control documentation.
• Evaluation: Support manufacturer qualification activities with Quality, Product Managers, Business Strategy & Operations and Procurement teams to evaluate vendor capabilities and identify technical gaps to inform viability of use as a third party manufacturer.
• Remediation: Oversee the manufacturer's delivery and lead any needed remediation efforts (when needed) to address updates to documentation.
• Review Manufacturer Design History Files (DHFs) and product development documentation: from the third party DHT product manufacturers
• Conduct Risk Management and computer systems validation (CSV) for products not classified as medical device, when necessary and per Roche’s global standard operating procedures (SOPs)
• Ensure compliance with Roche’s internal quality standards and global standard operating procedures (SOPs) for medical devices, including sourcing, clinical investigation, risk management, and clinical performance procedures.
• Draft or support product managers, clinical scientists, or other clinical teams with drafting technical documentation or risk management plans to meet Roche SOP, ISO standards or Health Authority Requirements.
• Support upskilling: activities and plans to train team members new to medical device development, design control, regulatory assessment and quality documentation activities.

Must Haves:

• BA/BS degree in Computer Science, Software Engineering, Informatics, Biomedical, related technical field or equivalent practical experience. Masters or advanced degree in Engineering, Quality Management, or related field.
• 7+ years’ experience in the medical device or pharmaceutical industry
• In-depth knowledge and experience executing ISO 13485, ISO 14971, IEC 62304,IEC 82304, IEC 60601-1, 21 CFR 820, 21 CFR Part 11, Annex 11, and GAMP 5, with a strong emphasis on medical device regulations and quality management systems
• Experience conducting ISO 14155 compliant clinical investigations for medical devices, ensuring regulat j4id10311893a j4it0731a j4iy26a