CEVA Logistics · 7 hours ago
Global Quality Healthcare Expert - NORTAM/LATAM
Chicago, IL
Full-time
Hybrid
Senior Level
5+ years expCEVA Logistics is a global logistics company, and they are seeking a Global Quality Healthcare Expert to ensure compliance with quality standards across various regions. The role involves supporting regional teams in maintaining certifications, conducting audits, and developing healthcare quality strategies.
Logistics
Hiring Manager
Sidnei De Lima
Responsibilities
Provide guidance to all Regional stakeholders on the expected level of compliance to Standards and Global Quality Management System Requirements
Support the Region Adherence to the Global Quality Management System and ensure compliance against relevant quality standards and Regulations (e.g. ISO 13485, GDP, GMP, FDA)
Provide support on new Healthcare business development by analysing Customer requirements, establishing the possibility of compliance to those while, whenever applicable, elaborating a plan with relevant stakeholders to mitigate gaps
Raise the profile of Healthcare Quality Assurance with Key internal stakeholders to drive right first time mind-set, promoting the highest levels of internal and external customer care at all levels
Contribute to the global audit program establishment based on Business needs and risk profile of the locations. Act as the Lead Auditor for Healthcare Internal and Supplier Audits while driving continuous improvement and compliance to CEVA quality requirements. Establish and maintain appropriate work streams to ensure readiness of internal/external audits and regulatory inspection for the region whenever applicable. Supports facilitating external Inspections with Authorities
Continuously contribute to the improvement of the Global QMS framework, by improving or developing new processes or any other suitable documentation
Ensure and support validation and Qualification activities aligned with global framework
Act as Support Partner with Design Solutions in ensuring compliance elements are considered and risk is designed out of operational processes to ensure legal compliance and efficiency as soon as possible
Prepare and provide training material, where required to ensure standards (e.g. GDP, GMP , ISO 13485) understanding within CEVA Organization
Develop and execute project plans to support Product compliance to healthcare standards (GDP, FDA regulation, GMP, ISO 13485)
Qualification
Required
University degree (Bachelor or Masters) or equivalent industry experience
5-8 years' experience in Quality and Management Systems implementation within Life science, medical devices or Pharma
Experience in Licenses management with authorities
Quality Standards (ISO 9001, GDP, GMP, ISO 13485, FDA regulation)
Detailed knowledge on Good distribution and manufacturing practices
Good understanding of ISO 13485, GDP and GMP requirements for validation and Qualification
Company
CEVA Logistics
CEVA provides world-class supply chain solutions for large and medium-size national and multinational companies across the globe.
10001+ employees
H1B Sponsorship
CEVA Logistics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
2023 (6)
2022 (8)
2021 (8)
2020 (13)
Funding
Current Stage
Late StageLeadership Team
Ashfaque Chowdhury
Chief Executive Officer, North America
Ahmed Jmeel
Interim CTO
Recent News
Business Journals
2023-05-03
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