Quality Assurance Specialist

Our Client Man & Science is a pioneering start-up specializing in the development of neuromodulation medical devices designed to alleviate severe headaches. They are committed to improving the quality of life for patients through innovative, high-quality solutions.

As a growing company, they are seeking a dedicated Quality Assurance Specialist.

We are seeking a motivated, early-career Quality Specialist to join our Quality & Regulatory team. In this role, you will work closely with the Head of Quality & Regulatory to design, implement, and maintain quality processes and records aligned with ISO 13485 standard and 21 CFR Part 820, specifically tailored for a R&D & clinical investigation environment. This is an exceptional opportunity for a biomechanics engineer looking to launch a career in medical device quality systems.

Key Responsibilities:

• Develop, document, and implement quality management processes, templates and records in compliance with ISO 13485 standard for R&D and clinical investigation activities.
• Serve as the internal expert for eQMS implementation, providing guidance and training to cross-functional teams, resolving system-related queries, and acting as the primary liaison with the eQMS provider.
• Liaise with cross-functional teams (engineering, regulatory affairs, clinical) to ensure quality requirements are integrated early in the design control process.
• Support design control activities, including creation and maintenance of design history files (DHF) and device master record (DMR) and device history record (DHR) and support regulatory submission of the clinical investigation application.
• Support the review and writing of testing protocols (together with experts) and alignment with the company strategy.
• Oversee document control systems, ensuring accurate filing, version control, and retrieval of quality records; manage internal document filing procedures and support external audits and regulatory inspections by providing organized and accessible documentation.
• Conduct quality reviews of internal processes and collaborate with team members to address nonconformities.
• Assist in (clinical) risk management activities to identify, evaluate, and mitigate risks related to product/process.
• Maintain training records for Man & Science personnel.
• Coordinate and track CAPA (Corrective and Preventive Actions) related to R&D projects (including clinical investigation) and support customer feedback management
• Provide occasional support to the Logistics/Supply Chain Coordinator (e.g. handling incoming/outgoing test samples, managing stock of test components, preparing shipments)

Required Qualifications:

• Bachelor’s or Master’s degree in Biomedical Engineering, Biomechanics, or related engineering discipline.
• Solid understanding of EU Medical Device Regulation (2017/475 as amended and MDCG guidance), ISO 13485 requirements, ISO 14971 risk management principles, Clinical investigation standards (ISO 1455 and ICH-GCP) and the relevant FDA 21 CFR parts related to Quality principles, Medical devices and Clinical Processes.

Preferred Experience :

• 1–2 years of experience in quality assurance or regulatory affairs within a medical device or related industry.
• Familiarity with medical device design control, risk management and product development lifecycle
• Hands-on experience with document control systems, change management and CAPA processes and audit methodologies
• Knowledge of software tools for document control and quality management (e.g., QMS platforms).

Key skills and Competencies :

• Structured and detail-oriented: ensures accuracy and completeness in documentation, process and data
• Quality focused: upholds high standards for compliance and documentation integrity
• Collaborative: works effectively with cross-functional teams and provides clear inputs into team’s meetings
• Strong analytical and problem-solving mindset: can identify issues, and propose corrective actions skills.
• Focused and disciplined: manages multiple tasks in a fast-paced R&D environment.
• Ability to work both independently
• Excellent written and verbal communication skills in English; proficiency in additional languages is a plus.

What our Client Offers:

• Opportunity to shape quality systems from the ground up in a dynamic R&D setting.
• Mentorship and professional development under seasoned quality and regulatory experts.
• Competitive compensation and benefits package.
• Collaborative, innovative work culture focused on impactful medical technologies.