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

Digital Health Technologies (DHTs), including those with medical device capabilities, are critical for enhancing patient value.

To address the varying measurement needs across our clinical trials, we partner with multiple third-party DHT manufacturers.

While DHTs are necessary to provide critical evidence to support medical decision making, they add complexity to study delivery and require different technical skills.

Addressing these complexities necessitates specialized support to assess regulatory identity, manage technical documentation, review manufacturer data, and coordinate change control activities.

A limited number of internal experts possess the technical skills (or DHT Technical Capabilities) required to manage regulatory identity assessments, documentation needs, and change control, leading to bottlenecks that delay study starts and risk the successful integration of DHTs.

We seek a dedicated quality systems engineer consultant to provide additional DHT Technical Capabilities to help us fill critical gaps for assessing regulatory identity, technical documentation, change control, remediation and upskilling activities to help train teams new to working with DHTs.

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 / Gx P 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 an advantage.
• Nice to Haves
• Cybersecurity experience - relevant ISO for products.
• Past experience leading training for ISO 14971, ISO 62304/SDLC.
• Past experience working with the Roche Group.
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