QA/RA Manager, Leiden

Job Summary

Rapidemic is seeking a QA Manager to join their team in developing next‑generation in‑vitro diagnostic devices. The role will lead the design, implementation, and continuous improvement of an ISO13485 Quality Management System (QMS) for in‑vitro diagnostic devices and shape the company’s quality culture.Job Details

Job Title: QA Manager Level: Senior Reports to: COO Type: Full‑time (40h/week) Location: BioPartner3, Leiden Bioscience Park, Zuid‑Holland Modality: On‑site, 1day/week remote possible Contract: Temporary, 1‑year with possible extension Start Date: As soon as possible, no later than August2026Responsibilities

Lead completion and implementation of the QMS, including establishing procedures, work instructions, and other applicable documentation. Maintain and continuously improve the QMS to ensure compliance with applicable regulations. Establish and maintain document control and change‑management processes, ensuring timely updates and cross‑functional alignment.Oversee creation and maintenance of all quality documentation such as procedures, work instructions, batch records, and test reports. Support regulatory submission strategies, ensuring QMS alignment with submission timelines. Lead clinical risk management and benefit‑risk analysis documentation for regulatory submissions.Establish traceability between requirements, design, testing, and clinical evidence. Plan and execute internal audits, supplier audits, and readiness activities for notified‑body assessments; manage audit schedules, findings, and corrective actions. Ensure effective CAPA management in a cross‑functional team, including root‑cause analysis, corrective actions, and effectiveness checks.Lead the QA team, define roles, responsibilities, and training plans. Educational Background

Bachelor’s or Master’s degree in Life Sciences or related field. Minimum 5‑7years of experience in QA/R&D roles within regulated medical‑device or IVD environments. Required Skills

Deep understanding of EU 2017/746 (IVDR) AnnexII/III technical documentation, classification rules, and performance‑evaluation requirements. Hands‑on experience maintaining and improving ISO13485 QMS, with proficiency in design controls, V&V, risk management, and CAPA. Experience building and auditing ISO13485 QMS systems. Experience leading QA teams or similar functions. Proficiency in creating and managing technical documentation. Experience with notified‑body audits and regulatory inspections. Demonstrated success managing CAPA, audits, and QMS processes.Excellent verbal and written communication in English. Attention to detail and proactive attitude. Preferred Skills

Professional certification such as CMQ/OE, CQIA, or equivalent. Previous experience setting up a full QMS system for IVD products. Risk Management (ISO14971): creation, maintenance, and review of risk‑management files, hazard analysis, and risk‑benefit evaluation. CAPA&nonconformance management, including root‑cause analysis and effectiveness checks. Internal and supplier auditing, including planning, executing, and documenting audits; experience with notified‑body assessments. Technical documentation writing: structure and maintain TD files, performance‑evaluation reports, and quality plans.Supplier quality management: qualification, monitoring, and performance review of critical suppliers. Data analysis&quality metrics: KPI dashboards, trend analysis, complaint data evaluation. Digital QMS tools: eQMS, LIMS, or other document‑management systems. Experience in early‑stage start‑up environments and building systems from scratch. Experience with molecular diagnostic devices. Familiarity with FDA regulation.Benefits

Competitive salary. Budget for training and personal development. Relaxed work atmosphere. Opportunity to explore and test your own ideas. Work experience in a European hub for life‑sciences innovation. Experience in the diagnostics industry.

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