Terumo Blood and Cell TechnologiesOur ability to grow, develop new capabilities and serve even more patients around the world depends on associates like you, who are passionate about our mission.
Thank you for considering this new opportunity to further unlock your potential.
Job Summary The Quality Specialist function is responsible for:
Processing all products quality complaints on disposables, equipment and system performance across the EMEA regionCreation and update of different documents to support the overall process (email templates in different languages, questionnaires, complaint forms, instructions for use, etc.).
Processing returns of disposables, spares and equipment from customers across the EMEA region
Processing release of reworked products in the region Providing support for managing documentation within the
Works with quality management, commercial, supply chain and other functional groups on quality system compliance issues. Develops or participates in the development of solutions to problems of intermediate complexity.
Drive the overall complaint process to ensure complaint handling meets the close out criteria KPI
Review, translation and entry of complaints from Customers into centralized database
Resolve questions/ambiguities with Customers, Commercial teams and CHU colleagues
Publish complaint acknowledgement letter to Customers, including supplementary questions for High Priority complaints
Organize as required return of defective product to enable investigation and provide follow up to ensure returns are not delayed Obtain Run Data Files (RDF) as required through liaison with Sales and technical Service teams
Coordinate the close out letter process for review, approval and distribution to customers by sales representatives.
Archive all documents related to complaint processing in complaint database, or other electronic storage location. Attend meetings, face to face and via conference calls, to review status of complaints with other EMEA QA team members and/or colleagues from the CHU.
Inventory, Customer Returns and Release Processing
Timely review of ERP system reports for inventory in return location, analyze each lot number (e.g. thermal history, shelf life, complaint history) and determine disposition as scrap or rework. Initiate rework process or scrap as required.
Timely review of ERP system reports for inventory in quality inspection location, analyze history by lot number (e.g. QC Hold, Recall, Controlled Distribution).
Review, assess and approve related production records and release product into unrestricted status if acceptable.
Liaison with Customer Service, Supply Chain, Technical Service and 3rd party warehouse
Communication of reworked product documentation to Manufacturing site for inclusion in Device History File (DHR) as required.
Support to Customer Care and Inventory (bench to repair releases, Short Shelf Life releases, correction of movements, etc.).
Conduct documentation control activities for the
EMEA QMS, with process owners organize release of new or revised SOP/WIN, associated lists and maintain records.
Give basic training on QMS and SOP/WINS
Complete QMS questionnaires and surveys requested by customers in the context of their supplier approval process
Participate to quality audits as required
Graduated Administration/Languages/Secretary
Experience in administrative and/or complaint handling function in an international and multicultural environment
Knowledge of any ERP system (SAP is an asset)
Basic knowledge of Management Systems:
Intermediate knowledge of MS Office Professional and Outlook
Skills In line with Terumo BCT's Core values
Exhibits commitment to organizational goals and guiding principles.
Demonstrated ability to complete assigned duties with a high level of accuracy and precision
Ability to work with minimal supervision and ability to take ownership and accept responsibility for actions and decisions
Demonstrated effective interpersonal skills and ability to represent the business in contacts with those both internal and external to the organization: strong team player, ability to seek and implement solutions to problems of intermediate complexity in a team environment and ability to work with a variety of personalities, including people of different cultures
Demonstrated ability to communicate effectively both verbally and in writing Required language skills: 2 EMEA languages including English, additional languages are an asset
Ability to orchestrate multiple activities at once under limited direction, to work under pressure and to tight deadlines, to establish priorities in an environment subject to change and manage a diverse workload
Ability to maintain the confidentiality of both verbal and written information
Demonstrated ability to generate creative ideas for process improvement
This is a fixed-term contract position until December 2026
May be required to travel domestically and internationally one or two times a year
What We Offer The opportunity to work for a global leader in blood and cell technologies serving customers in more than 130 countries
Collaborate with talented colleagues who demonstrate our core values of respect, integrity, quality, creativity and care and are guided by our Mission to 'Contributing to Society through Healthcare'
An environment that encourages continuous learning, growth mindset and ownership
Competitive salary and a wide range of benefits A flexible and hybrid workplace
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