Quality Systems Analyst

Summary

Join Idoven, a leading HealthTech and AI startup, as a Quality Assurance professional. You will play a crucial role in maintaining the company's Quality Management System (QMS), ensuring compliance with relevant standards like ISO 13485 and FDA regulations. Responsibilities include managing customer feedback, supplier evaluations, and audit readiness, as well as leading quality improvement initiatives. The ideal candidate possesses a Bachelor's degree (Master's preferred), 2+ years of experience in Quality Assurance within a regulated industry (medical devices ideal), and a strong understanding of quality system standards. Idoven offers a flexible remote work environment, comprehensive health insurance, generous paid time off, professional development opportunities, and a vibrant team culture.

Requirements

• Bachelor’s degree required
• 2+ years of experience in Quality Assurance or Quality Systems Management within a regulated industry, ideally medical devices
• Solid understanding of quality system standards and regulations, including ISO 13485, ISO 9001, EU MDR, and FDA 21 CFR 820
• Hands-on experience managing Non-Conformance and CAPA processes
• Strong ability to identify process gaps and implement improvements effectively
• Analytical mindset with excellent organizational skills
• Ability to collaborate cross-functionally with various teams
• Fluency in English (Spanish is a plus)

Responsibilities

• Assist the Head of Quality in maintaining Idoven’s QMS to ensure compliance with applicable standards, included but not limited to ISO 13485, IEC 62304, ISO 82304, ISO 14971, and ISO/TR 24971
• Stay informed of evolving quality and regulatory trends to drive continuous compliance
• Support the processing of customer feedback and complaints, ensuring timely and compliant responses
• Manage supplier evaluations and re-evaluations to ensure compliance with quality standards
• Assist in ensuring the audit-readiness of the QMS by preparing for internal and external audits, updating processes, and maintaining compliance
• Lead initiatives to establish and implement quality improvement programs
• Coordinate post-market data collection and analysis to support product safety and performance monitoring
• Oversee document management processes to ensure policies, procedures, and records are up-to-date and accessible
• Contribute to maintaining risk management documentation, including risk analyses and FMEAs
• Support company-wide training initiatives to promote adherence to quality and compliance best practices

Preferred Qualifications

• Master’s degree preferred
• Experience managing supplier quality processes
• Familiarity with post-market surveillance and quality data analysis
• Knowledge of risk management standards (e.g., ISO 14971)
• Experience with software as a medical device (SaMD) or AI-driven medical devices

Benefits

• Unlimited remote working environment, where you can choose to work from home and attend our Madrid office whenever you want to
• Learning and development opportunities and training budget
• Flexible Remuneration
• Health Insurance
• Access to Wellhub (Gympass), empowering your physical and mental wellness!
• 23 holidays, your birthday off, and December 24th and 31st half days to celebrate!
• Regular team events and Thursday happy hours