QMS/ISO Quality System Engineer

Raidium

About the company Raidium is building a foundation Model for precision medicine in radiology. Our first release, Curia is already state of the art. We aim to broadly democratize  access to imaging biomarkers for both clinical and research applications through a biomarker factory. Our model is embedded in a new type of solution for the radiologist that enables a revolutionary AI-native workflow. Thanks to a 16M€ seed round raised in November 2024, Raidium is expanding its team. We are developing a medical device designed to operate at the intersection of deep learning and diagnostic precision. While our Quality Management System (QMS) is already established and operational, we are now entering a critical phase of our growth. We have initiated the formal regulatory pathways (MDR/FDA) to bring our AI-native solutions to the global market. The team The founders of Raidium are experts in radiology and machine learning from Owkin, bringing together extensive experience from both fields. Paul Herent, CEO, is a radiologist and former interne des hôpitaux de Paris, with a Cogmaster (ENS) and PSL background, and has published pioneering research on deep learning in radiology.  Pierre Manceron, CTO, is a Centrale Paris engineer specialized in Applied Mathematics and Machine Learning, who previously led machine learning projects at Owkin.  Sebastian Schwarz, COO, holds a double degree in X-HEC Data Science & Business, who previously worked as a Strategy & Operations Director at Owkin, where he developed Owkin’s strategic vision and operational agency. Our team brings together strong academic foundations (Polytechnique, Ponts, MVA) and deep medical, AI, and business experience from leading medical and tech companies such as Owkin, Cardiologs, Datadog, and Meta, all united by a mission to revolutionize radiology through cutting-edge technology. The role  As the Head of QARA at Raidium, you will play a pivotal role in defining our regulatory strategy and ensuring our AI-native solutions meet the highest standards of safety and excellence. Lead the global regulatory strategy (MDR, FDA) to get our AI medical devices to market Manage the submission process, coordinating technical files and clinical data to secure product certifications and clearances. Manage and mentor a Junior QARA, overseeing their daily tasks and supporting their professional growth within the team. Maintain and improve our QMS, keeping our quality processes lean and effective as the company scales. Act as the main contact for Notified Bodies and authorities, handling all external audits and regulatory communications. Partner with R&D and Product teams to ensure "Compliance by Design," guiding the team through risk management and software standards.

The Exploration Company

Here at The Exploration Company, we are developing, producing, and operating Nyx, a modular and reusable space orbital vehicle that can eventually be refuelled in orbit and that can carry cargo - and potentially humans in the longer run. The operations team is looking for a Site Director (Germany) to own safe, compliant, and efficient operations across our sites in Munich (includes integration halls, offices, labs, and test areas). Reporting to Lead Operations, you will lead vendors or work hands-on to deliver facilities reliability, compliant execution, and friction‑free activities. RESPONSIBILITIES * Lead day‑to‑day test site operations: reception, goods‑in/out, utilities, janitorial, waste, test site activities (together with the site manager and logistics responsible) * Plan and execute preventive and corrective maintenance; manage work orders, spares, and service contracts to keep critical utilities running. * Run office/lab/test‑area fit‑outs and moves: contractor pre‑qualification, risk assessments, permit‑to‑work (PTW), and safe commissioning in occupied areas. * Manage leases and landlord relationships; track obligations, service charges, and issues to resolution. * Coordinate inbound/outbound logistics, including dangerous goods with certified partners; ensure yard/dock safety and traffic plans. * Implement the company EHS Management System on site (defined by the EHS Engineer): chemical and waste controls, PPE, and legal registers; drive incident reporting, root‑cause analysis, and corrective actions. * Own emergency preparedness: evacuation plans, drills, first‑aiders/fire wardens, and liaison with local authorities as needed. * Operate physical security: access control/badging, visitor management, CCTV, key control, and guard services. * Implement export‑control physical safeguards (aligned with our Internal Compliance Program): controlled rooms/cabinets, visitor escorting, signage, and disposal procedures. * Build and manage the site OPEX/CAPEX budget; run project stage‑gates, vendor SOWs, and change orders; deliver projects on time and on budget with as‑builts and O&M docs. * Provide accurate records and reporting for audits, Quality Management System expectations, and ESG/B‑Corp data (energy, water, waste, recycling). * Lead and coach the test site team and vendors; communicate proactively about works, outages, and changes. QUALIFICATIONS / SKILLS * 5+ years leading multi‑disciplinary site or test‑site operations in Germany (industrial, aerospace, or high‑hazard environments). * Proven experience planning and executing propulsion/engine or high‑energy tests (stand allocation, crew rostering, TRR/DR cadence, anomaly management). * Strong knowledge of German EHS and DREAL environmental regulations (particularly with ICPE sites) and practical experience with contractor controls in hazardous operations. * Comfortable hands‑on during test campaigns; disciplined communication and decision‑making under time pressure. * Familiarity with cryogenic and high‑pressure fluid systems, instrumentation/DAQ, and interlock/safing concepts (you will not design these, but must govern readiness and safe operation). * Demonstrated success delivering fit‑outs/commissioning, running maintenance programs, and closing audit actions. * Budget ownership (OPEX/CAPEX), vendor negotiation, and basic project governance. * Familiarity with QMS expectations (ISO 9001/9100), CMMS tools, and MS 365/SharePoint; basic ability to read/redline site drawings. * Languages: German (native‑level) and English (professional working proficiency). * Leadership: organized, service‑oriented, decisive; able to set expectations and coach teams and suppliers; willing to support off‑hours/weekend test ops when needed. Why you should join us! What makes us special here at The Exploration Company and why we think you will enjoy working here is:   * We’re Agile - we make decisions fast whilst keeping our goals and systems in mind  * We’re Open and Collaborative - we are transparent about risks and obstacles, so that we can cooperate to overcome them   * We have a lot of Fun - we refuel our energy knowing we are democratising space. It’s a wonderful and rare opportunity, are YOU up for the challenge?   We'd love to hear from you if you wish to be a part of our journey. Please submit your CV now for immediate consideration and we will be in touch shortly.    The Exploration Company is an equal opportunity employer and values diversity. We do not discriminate based on race, religion, colour, national origin, gender, sexual orientation, age, marital status or disability status. Relocation assistance is provided for those willing to relocate including visa sponsorship where applicable.   All offers are contingent upon the successful completion of a background check, which will be subject to the country, role, and project you applied for. By submitting your application, you acknowledge and agree that any offer of employment may be conditional upon successful condition of this check. The Exploration Company partners with Zinc Work Limited located in the UK (Zinc), a third-party provider, to ensure this process as efficient and transparent as possible. If applicable, you will receive an email from Zinc upon acceptance of your offer with a link to a secure portal where you can provide the required information to Zinc.

Scarlet

We pull medical technology from the future to solve human health.   Authorised by governments around the world to assess medical AI, we remove unnecessary delays from every regulatory approval we do so patients get devices from the future, today. We are proud to count the world’s most ambitious companies building medical technology as customers. You will be joining a team with product-market fit, flowing data, and exponentially growing revenue. ABOUT THIS ROLE: Scarlet’s Quality Team plays a pivotal role in ensuring that Medical Device Manufacturers meet and exceed the Quality Management System (QMS) requirements laid out by the regulators. With deep expertise in regulatory standards, the team designs efficient workflows that enable timely and secure QMS audits of the next generation of Healthtech products. The Quality Team's goal is to ensure full compliance and operational excellence—both within Scarlet and for Medical Device Manufacturers. YOUR RESPONSIBILITIES: * Get authorised to audit and certify the quality management systems of the most innovative healthcare companies in the world * Decompose, interpret and implement relevant quality requirements (ISO 13485, ISO 17021, EU MDR, ISO 42001, ISO 27001, etc.) * Optimise the assessment of customer data by designing efficient audit processes * Be involved in maintaining and expanding Scarlet’s approvals in various jurisdictions and technologies THE KEY SKILLS: * Education - Bachelor’s degree in engineering, software engineering, computer science, physics or equivalent * Work experience - Minimum of four years of professional experience in the field of medical devices * Work experience - Minimum of two years of professional experience in quality management (e.g. ISO 13485, EU MDR, ISO 14971, etc.) * Work experience - Experience auditing against medical device quality management requirements (e.g. ISO 13485, EU MDR, ISO 14971, etc.) * Technical experience - Minimum one year of practical experience working with medical device software, demonstrating knowledge of relevant requirements (e.g. IEC 62304, IEC 82304, etc.), software development methodologies, cyber security etc. DESIRABLE SKILLS: * Work experience - Experience working with ISO 27001 * Analytical reader - You feel comfortable with reading normative texts and analysing and interpreting requirements to extract the essential information * Ferociously curious - You like going down rabbit holes, understanding deeply how things work, and challenging the status quo * Highly adaptable - You have worked in different environments and like operating with autonomy on sometimes ambiguous tasks THE INTERVIEW PROCESS At Scarlet, we have built our interview processes to ensure you get to fully understand the role and Scarlet’s culture, and to ensure we get to know about your skills, expertise, and who you are. Here is what to expect: 1. Recruiter Screen and Intro call with Hiring Manager - 45 mins 2. Regulatory and Auditor Skills Interview with Quality Team - 45 mins 3. Cross-functional Problem Solving Interview with Operations Team - 45 mins 4. Founder Interviews - 2x30 mins 5. References 6. Offer