Staff Medical Quality Systems Engineer
Analog Devices
Producción de semiconductores
Valencia, Comunidad Valenciana - Spanien
Project Manager Sénior / Especialista sénior
Experteer Overview
As Staff Medical Device Quality Systems Engineer, you will oversee the Medical Quality Management System (MQMS) strategy and continuous improvement on a global scale. You will drive regulatory readiness and partner with R&D, Regulatory Affairs, Clinical, and Manufacturing to embed quality across the product lifecycle. You’ll lead cross-functional initiatives, audits, and data-driven quality improvements that support safe, compliant medical devices. This role offers the chance to shape quality culture and regulatory success in a global organization.
Responsabilidades
- Strategize and implement MQMS improvements in line with ISO 13485, 21 CFR 820, EU MDR and other standards
- Develop and govern quality system processes (CAPA, Internal Audits, Document Control, Change Management, Training, Management Review)
- Own MQMS training architecture, content, delivery, and effectiveness globally
- Serve as SME during audits (FDA and Notified Body) and lead readiness and responses
- Analyze quality metrics, identify systemic trends, drive cross-functional, data-driven improvements
- Provide strategic input for regulatory submissions (FDA 510(k), PMA, EU MDR)
- Oversee CSV/CSA activities and 21 CFR Part 11 alignment
- Maintain design history files, risk management docs, and post-market surveillance
- Collaborate with R&D, Regulatory Affairs, Clinical, and Manufacturing to integrate quality across lifecycle
- Mentor engineers and partners on quality principles and continuous improvement
- Represent Quality in strategic forums and provide system-level guidance
- Lead root cause investigations and CAPAs with advanced quality tools
- Support validation planning for new designs and processes
- Lead FDA and regulatory inspection readiness and remediation actions
Requisitos principales
- Bachelor’s degree in Engineering, Life Sciences, or related technical field (Master’s preferred)
- 5+ years in medical device quality oversight across development to commercialization lifecycle
- Strong knowledge of FDA QSR, ISO 13485, ISO 14971, EU MDR and GMP
- Proven experience leading quality systems (CAPA, change control, document management, training)
- Auditing/inspection experience (FDA and Notified Body)
- Knowledge of FDA 510(k), PMA requirements and submissions maintenance
- Proficiency with quality tools and eQMS platforms
- Risk management per ISO 14971 and post-market surveillance integration
- Root cause analysis techniques (5 Whys, Fishbone, FTA)
- Excellent communication, leadership, and cross-functional collaboration skills
- Lean, Six Sigma or continuous improvement certifications desirable
Descripción del puesto
As Staff Medical Device Quality Systems Engineer, you will oversee the Medical Quality Management System (MQMS) strategy and continuous impr…
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