MedQuore is expanding its international network of independent experts in Quality, Regulatory, and Compliance to support projects for Medical Devices, IVD, Pharma, Biotech, CDMO, and other regulated Life Sciences environments. We are seeking senior professionals with demonstrable experience in audits, quality systems, and regulatory compliance, who are interested in collaborating with MedQuore on ad-hoc projects under a freelance / independent contractor arrangement. Collaboration will be project-based, depending on specialization, location, availability, and each client’s specific needs. **Key Areas of Interest** * Supplier and third-party audits * Internal audits * GMP / GDP / GCP * ISO 13485 * MDR / IVDR * Quality Management Systems * CAPA and remediation * Inspection readiness * Supplier Quality * Clinical Quality * CSV / CSA * SaMD / IEC 62304 * Regulatory & Quality assessments **Responsibilities** * Conduct audits and assessments according to the defined scope for each project. * Review documentation, processes, and objective evidence. * Identify and document findings clearly, consistently, and with sound technical justification. * Prepare professional audit or assessment reports. * Participate, where applicable, in CAPA follow-up and remediation activities. * Adhere to MedQuore’s applicable quality standards, procedures, and methodology for the project. * Maintain strict confidentiality regarding client information. * Disclose any potential conflict of interest prior to accepting an assignment. **Profile We Are Seeking** * Significant professional experience in Life Sciences, preferably **10+ years**. * Solid experience in Quality, Regulatory, Clinical Quality, Manufacturing Quality, or Supplier Quality. * Proven hands-on experience conducting audits, assessments, or compliance projects. * In-depth knowledge of one or more relevant standards/regulations. * Ability to work independently and communicate effectively with senior client teams. * Excellent report writing skills. * Professional English; additional languages are valued. * Availability to work as an independent professional / contractor. * Occasional availability for travel when a project requires on-site activity. **Especially Valued** * Experience as a Lead Auditor. * Prior experience with Medical Device, IVD, Pharma, Biotech, CRO, or CDMO manufacturers. * Experience with Notified Bodies, certification bodies, or internationally regulated companies. * Relevant certifications in auditing or Quality. * International experience and ability to conduct audits across multiple countries. * Prior experience as Quality Director, Quality Manager, QA Manager, Supplier Quality Manager, or equivalent roles. **Collaboration Model** This is not a traditional full-time employment position. Selected experts will join the **MedQuore Expert Network** and may be considered for projects based on their experience, availability, location, and specialization. Collaborations may be structured on an hourly, daily, or fixed-project basis. Fees will be negotiated individually per profile and assignment, considering experience, scope, complexity, and project location. **Engagement Type:** Freelance / Independent Contractor **Location:** Remote, with possibility of on-site projects **Scope:** Spain, Europe, and international **Indicative Rate:** 60–100 €/hour, depending on profile and project MedQuore selects its experts based on technical expertise, professional track record, regulatory competencies, and real-world audit or Quality experience. Salary: 60.00€–100.00€ per hour Benefits: * Flexible working hours Experience: * Quality audits: 8 years (Mandatory) Language: * English (Mandatory) * French (Desirable) * Portuguese (Desirable) Work Location: Hybrid remote work in Madrid, Madrid province (Madrid)
David Muñoz
Indeed · HR
David Muñoz
Indeed · HR
