Chicago. Il, US
Global Quality Healthcare Expert - NORTAM/LATAM
CEVA Logistics is one of the leading logistics companies globally, with over 1,500 facilities in more than 170 countries offering a complete range of contract logistics, freight forwarding, transportation and distribution management services. It offers supply chain support, along with logistics consultation, industry specific customization, global level freight management and system implementation.
At CEVA, we put people first and we strive for better ways in everything we do; our culture is embodied by Boldness, Imagination, Exemplary and Excellence. With these values at the core of our business, our workplace employs 110,000 diverse, cohesive team members who hold each other accountable and encourage each other to create a safe, and inclusive work environment.
Support the regions delivering the level of compliance to standards ( and Global Quality Management Framework required by CEVA while boosting continuous improvement culture within the organization.
Support Regional and Global teams maintaining Certification and Licenses for all Relevant Quality Standards.
Deliver expert and competent support to all relevant departments and stakeholders in order to support designing, improving and implement Processes to sustain standards compliance, while building and sharing knowledge across the Region.
Support the Global Audits Program (Internal ad Suppliers) by planning and performing Internal Audits / Suppliers Audits across the Region(s) enabling compliance to Customer and Standards requirements.
Act as the link with commercial teams on Global new business development ensuring that Quality healthcare customer requirements are analyzed, understood and fulfilled. Analyze and provide feedback on CEVA readiness to fulfill new or existing customer requirements.
Lead the development, implementation and continued improvement of healthcare quality strategy within the region under your responsibility.
WHAT ARE YOU GOING TO DO?
- 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).
- 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.
WHAT DO WE HAVE TO OFFER?
With a genuine culture of reward and recognition, we want our employees to grow, develop and be part of our journey. There’s no doubt that you will be compensated for your hard work and commitment so if you’d like to work for one of the top Logistics providers in the world then please do get in touch to find your next role.
ABOUT TOMORROW
We value your professional and personal growth. That’s why we share plenty of career opportunities for you to thrive within CEVA. Join CEVA for a challenging career.
At CEVA we are committed to creating a safe and healthy work environment.
We offer:
- A Competitive Compensation PackageComprehensive Health & Dental Benefits
- Professional Development Opportunities
- Continuing Education
CEVA is an equal opportunity employer who agrees not to discriminate against any employee or job applicant and is committed to a diverse and inclusive workforce. Accommodations are available upon request for candidates with disabilities taking part in all aspects of the selection process.
We thank all candidates for applying, however, only successful candidates will be contacted for an interview.
Nearest Major Market: Chicago