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Quality System Engineer (m/f/d) with DHT Technical Capabilities – Basel | JobRevolt

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Digital Health Technologies (DHTs), including those with medical device capabilities, are critical for enhancing patient value, and Roche partners with multiple third-party DHT manufacturers to address varying measurement needs across clinical trials. A limited number of internal experts possess the technical skills required to manage regulatory identity assessments, documentation needs, and change control, leading to bottlenecks. This role provides additional DHT Technical Capabilities to fill critical gaps in assessing regulatory identity, technical documentation, change control, remediation and upskilling.

Aufgaben

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; 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; 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 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

Profil

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 regulatory and ethical standards are met
Experience executing ISO / IEC 27001 and cybersecurity aspects related to development of medical device products
Software Validation & Testing: Expertise in Computerized System Validation (CSV) and software quality assurance, with an ISTQB Test Manager certification
Experience with GCP / GxP practices and GMP
Experience in working with the Center

Quality System Engineer (m/f/d) with DHT Technical Capabilities

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Über den Job

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