Overview
Quality Assurance Specialist Jobs in Amiens, Hauts-de-France, France at Surgitec Robotics
Title: Quality Assurance Specialist
Company: Surgitec Robotics
Location: Amiens, Hauts-de-France, France
Surgitec Robotics develops Surge One, a new generation of AI-assisted surgical robotics designed for hard-tissue procedures such as neurosurgery, spine, orthopedics and ENT.
Role
In a demanding regulatory environment (MDR 2017/745, FDA 21 CFR Part 820, ISO 13485), the Quality Assurance Specialist acts as a catalyst for innovation: turning quality requirements into drivers of development rather than obstacles.
The position holder is the key point of contact for Quality-related matters across all internal teams, fostering a culture in which quality is integrated from the design stage (Quality by Design).
The QA Specialist contributes to defining and implementing Surgitec Robotics’ overall quality strategy, supporting the development, conduct of clinical trials, industrialization, and market launch of the Surge One® robotic platform.
The QA Specialist ensures compliance of the Quality Management System (QMS) and serves as the primary contact for notified bodies, as well as the lead reference for the preparation, coordination, and hosting of audits and inspections.
Attributions
A. Owner of the Quality Management System (QMS)
- Create, maintain, and continuously improve the QMS in compliance with regulations of target markets (e.g., ISO 13485, MDR, and QMSR)
- Manage and update QMS procedures, work instructions, and forms, and support their implementation through the establishment of training and communication processes
- Lead internal audits and conduct supplier audits
B. Strategic Partner to Development Teams
- Integrate quality and regulatory requirements from the design phase (Design Controls) by supporting R&D, Hardware, Software, and Clinical Affairs teams using a risk-based approach
- Participate in FMECA workshops, risk analyses, and design reviews, positioning quality as an enabler
- Propose pragmatic solutions to regulatory challenges encountered during development
- Coordinate product risk management in accordance with ISO 14971
C. Non-Conformities, CAPA & Continuous Improvement
- Manage the process for handling non-conformities and complaints (post-market)
- Drive corrective and preventive actions (CAPA) with the relevant teams (post-market)
- Analyze quality data and propose measurable improvement plans
- Contribute to management reviews and prepare quality indicators (KPIs)
D. Supplier & Subcontractor Management
- Qualify and evaluate suppliers
- Write and negotiate Quality Agreements with strategic partners
- Manage supplier non-conformities and related action plans
Expected profile
Education
- Master’s degree (MSc or Engineering degree) in Quality, Biomedical Engineering, Life Sciences, Mechatronics, Pharmacology, or equivalent
- A specialization or certification in quality management (ISO 13485 Lead Auditor, ASQ CQE, RAPS RAC) is a strong asset
Experience
- 5 to 7 years of experience in a quality role within complex medical devices (hardware, software, and artificial intelligence)
- Proven experience with Class IIb or III products (active medical devices, implantables, robotic surgery highly valued)
- Experience in robotics is a plus
- Participation in at least one market launch (CE marking under MDR and FDA 510(k)/PMA submission) is required
- Experience in a startup or innovative SME environment: ability to build quality systems “from scratch”
Knowledge
- Strong command of the European Medical Device Regulation MDR 2017/745 and standards ISO 13485, ISO 14971
- Knowledge of standards IEC 62304 (medical device software), IEC 60601 (electrical safety), and ISO 10993 (biocompatibility)
- Understanding of design and development processes: Design Controls, DHF, RMF, DMR, DHR
- Solid foundation in risk management
- Knowledge of FDA 21 CFR Part 820 and QSR/QMSR is a plus
- Basic understanding of cybersecurity and computer system validation (CSV/CSA) applied to medical devices
- Knowledge of regulations related to Artifcial Intelligence
- Knowledge of cybersecurity requirements
Know-how
- Document writing and management: procedures, protocols, technical files
- Conducting internal and supplier audits
- Implementation and monitoring of CAPA processes and non-conformity management
- Use of QMS tools
- Development and monitoring of Quality dashboards (KPIs, management reporting)
- Ability to write clear regulatory summaries for non-technical audiences
Interpersonnal skills
- Facilitator with a solution-oriented mindset
- Start-up spirit: agility, pragmatism, ability to prioritize in a resource-constrained environment
- Cross-functional leadership: ability to influence without formal authority and rally teams around a Quality culture
- Rigor and organization without excessive bureaucracy: applying the “right-sized quality” principle
- Intellectual curiosity: active monitoring of regulatory and technological developments in the sector
- Resilience and adaptability: comfortable with uncertainty and pivots inherent to a start-up environment
Language
- French: bilingual, native
- English: fluent (C1) — documentation, audits, international partners, etc.
Why join us ?
- Make a real impact : Contribute to technologies that improve surgical precision and patient outcomes, transforming lives every day.
- Work at the forefront of innovation : Be part of a pioneering team developing next-generation surgical robotics, combining engineering, AI, and healthcare expertise.
- Collaborate with passionate experts : Work alongside talented professionals from diverse backgrounds, all driven by a shared mission to advance healthcare.
Position based in Amiens or Montpellier
Opportunity for partial remote work
