Transportation Commercial Quality Specialist
Hybrid · Zug, Zug, Switzerland or Leeds, England, United Kingdom
Job Summary
EMEA CQSS Specialist responsible for supporting regional Commercial Quality and Safety Surveillance activities, ensuring quality system compliance, post-market surveillance and vigilance, and cross-functional collaboration to protect patient safety and regulatory readiness. Key activities include maintaining CQSS documentation, participating in complaint handling and trend analysis, supporting audits and regulatory inquiries, and contributing to continuous improvement of CQSS processes, tools, and reporting. Strong emphasis on quality systems knowledge, regulatory awareness, and effective communication across Regulatory Affairs, Medical Safety, and Operations. Travel up to regional locations may be required; multilingual capabilities and familiarity with EU MDR/IVDR are advantageous.
Required Qualifications
- Bachelor’s degree in a scientific, engineering, healthcare, or related discipline (advanced degree preferred)
- 2–4 years of relevant experience in Quality, Compliance, Regulatory Affairs, or related function in regulated industry
- Working knowledge of quality systems and compliance requirements (e.g., ISO 13485)
- Experience supporting investigations, documentation, and quality records
- Strong attention to detail and ability to manage multiple priorities
- English language proficiency
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