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

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 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 for Devices and Radiological Health (FDA), EU Health Authorities/MDR, and Notified Bodies
• Track record of effectively working in a matrix environment with global team members
• Fluent in English, German is of advantage

Benefits

• Become part of one of the most prestigious pharmaceutical companies and actively shape the future of healthcare
• Experience a work culture that promotes diversity and inclusion and where all employees feel valued.
• Work on a state-of-the-art campus featuring green spaces, meeting areas, and an inspiring atmosphere
• Work with modern and up-to-date tools in an innovative work environment
• Start with a professional onboarding process and a thorough introduction to your new role during the Welcome Days
• Benefit from financial support for your professional development plans
• Enjoy a selection of high-quality meals in modern staff restaurants
• As part of a sustainable mobility concept, on-site parking spaces are available to you (subject to eligibility criteria)
• Take advantage of unbeatable, year-round discounts at renowned retailers and over 200 top brands
• Benefit from fleet discounts when purchasing new cars or receive constant fuel discounts with our fuel card