QARA Manager at QMENTA IMAGING S.L.

Barcelona, Catalonia, Spain -

Full Time

Start Date

Immediate

Expiry Date

01 Jul, 26

Salary

0.0

Posted On

02 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Regulatory Affairs, Compliance, Documentation Control, Audits, CAPA, SOPs, GDPR, HIPAA, ISO Standards, Communication, Detail-oriented, Problem-solving, Biomedical Engineering, Health Tech, Software

Industry

Software Development

Description

QARA Manager Are you passionate about technology, regulatory strategy, and making a real impact in global healthcare? At QMENTA, we are transforming neuroimaging with AI and cloud-based solutions. We’re looking for a QARA Manager to lead our regulatory strategy and ensure compliance across our advanced healthcare imaging and data management platforms. Who we are QMENTA is a cutting-edge software company providing a comprehensive platform for managing, analyzing, and interpreting medical images in research and clinical trials. Our technology enables faster diagnosis of neurological diseases like Parkinson’s, Alzheimer’s, and multiple sclerosis, and accelerates clinical trials through powerful AI-driven tools. Our scalable cloud-based infrastructure integrates AI-powered imaging biomarkers and automated workflows to enhance medical imaging accuracy and collaboration across global research teams. If you're excited to drive innovation in healthcare and work with mission-driven colleagues, QMENTA is the place for you! What You'll Do • Own and continuously improve QMENTA's Quality Management System (QMS), ensuring full compliance with applicable standards and regulations for a software-as-a-service neuroimaging platform. • Lead the Documentation Control and Documentation Change Control processes, maintaining accuracy and traceability across all QMS artifacts. • Design, coordinate, and lead internal and external QMS audits; prepare all required documentation and manage responses to findings. • Define, measure, and report on quality KPIs to senior leadership, including preparation and facilitation of Management Review Meetings. • Drive the full lifecycle of Corrective and Preventive Actions (CAPA), ensuring timely resolution of non-conformities. • Create, maintain, and implement Standard Operating Procedures (SOPs), policies, and work instructions; lead adoption across teams. • Serve as the primary point of contact for GDPR and HIPAA compliance within the QMS, generating and maintaining all required records and evidence. • Lead QMS onboarding for new employees and deliver ongoing internal training to ensure consistent implementation of quality processes. • Sign and approve QARA-related documents on behalf of the QARA function. • Stay current on evolving regulations and proactively assess their impact on QMENTA's compliance posture. • Maintain traceability of documentation from Engineering and Customer Success teams in line with our QMS and SDLC (Design, Development, and Maintenance). • Manage all HR-related records within the QMS in collaboration with the People & Legal team (onboarding, training records, job descriptions, org chart). • Support vendor qualification processes, including participation in Vendor Questionnaires from CROs and other partners. • Assist with premarket FDA, CE, and other international regulatory submissions as needed. • Act as a liaison to external auditors, regulatory bodies, and enterprise customer security/compliance teams. What We’re Looking For • 5+ years of hands-on experience in Quality Assurance and/or Regulatory Affairs within software, health tech, or biotech environments. • Demonstrated ability to own and manage a QMS independently, without day-to-day supervision. • Deep working knowledge of FDA 21 CFR Part 11 & 820, ISO 27001, SOC 2, GDPR, HIPAA, IEC 62304 and practical experience implementing or maintaining compliance under these frameworks. • Familiarity with ISO 13485, FDA 510(k), ISO 14971, and GxP principles is a strong plus. • Proven experience in software companies (SaaS, healthtech, or life sciences software); experience in clinical research or neuroimaging environments is a bonus. • Strong track record of designing and leading internal/external audits, CAPA processes, and Management Review cycles. • Exceptional written and verbal communication skills in English; Spanish is a plus. • Detail-oriented, structured thinker who can manage multiple workstreams simultaneously with minimal oversight. • Proactive, solutions-focused approach — you identify gaps before they become problems. • Degree in Biomedical Engineering, Engineering, Life Sciences, or a related field. What We Offer 23 paid vacation days per year, plus local public holidays. Flexible compensation plan – including meal vouchers and private health insurance. Hybrid work model: 2 days per week at the office, with flexible schedule. Modern office in Barcelona, well-connected by public transport. Inclusive and diverse culture where your voice matters and you can make a difference. Ready to make a real-world impact? If you’re excited by the idea of leveraging regulatory expertise to drive innovation in healthcare, apply now! We’d love to hear from you. We Are an Equal Opportunity Employer QMENTA is proud to be an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees. We welcome applicants of any race, color, religion (or no religion), national origin, gender, gender identity, sexual orientation, age, marital or civil status, pregnancy, disability, or any other legally protected characteristic. At QMENTA, we believe that a diverse team makes better decisions and drives innovation.

Responsibilities

The QARA Manager will own and improve QMENTA's Quality Management System, ensuring compliance with applicable standards. They will lead audits, manage quality KPIs, and drive corrective actions.