4 дня назад
Manager Quality Distribution (Medical Devices)
66 000 - 103 000€
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manager Quality Distribution (Medical Devices): Providing end-to-end quality oversight for global distribution centers, third-party logistics providers, and post-sterilization laboratory testing with an accent on GDP compliance, regulatory alignment, and supply continuity. Focus on managing deviations, CAPAs, change controls, audit readiness, risk-based testing, and continuous improvement across a global medical-device network.
Location: Roosendaal, Netherlands
Salary: €66,000–€103,000 gross annually
Company
is an independent, employee-owned healthcare company developing, manufacturing, and marketing ostomy care, continence care, and critical care products worldwide.
What you will do
- Provide quality governance for global distribution centers and third-party logistics providers, ensuring compliance with Good Distribution Practices and medical-device regulations.
- Establish and harmonize distribution quality standards, procedures, agreements, metrics, and KPIs across regions.
- Oversee deviations, nonconformances, CAPAs, change controls, investigations, and risk mitigation for distribution activities.
- Coordinate post-sterilization laboratory testing, including testing strategies, sampling plans, result trending, and product release support.
- Support internal, external, and regulatory audits and drive inspection readiness across distribution sites and logistics partners.
- Lead and develop global distribution quality team members and partner with Supply Chain, Logistics, Operations, Sterilization, Manufacturing, and Regulatory Affairs.
Requirements
- Bachelor’s degree and 12–15 years of related experience.
- Bachelor’s degree in engineering, life sciences, or a related field; an advanced degree is preferred.
- Significant Quality Assurance experience in a regulated medical-device or pharmaceutical environment.
- Demonstrated experience in distribution quality, GDP, logistics, and third-party oversight.
- Working knowledge of sterilization processes and post-sterilization testing requirements.
- Strong understanding of FDA, ISO 13485, MDSAP, and other global regulatory requirements, with the ability to lead cross-functional teams and manage quality risk.
Culture & Benefits
- Employee-owned company focused on making life more rewarding and dignified for patients and customers.
- Collaboration across global Quality, Supply Chain, Operations, Sterilization, and Regulatory Affairs teams.
- Work supporting healthcare products distributed across nearly 80 countries.
- Commitment to quality, accountability, proactive risk management, inclusion, ethics, and data privacy.
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