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Quality Specialist EMEA

Date: Aug 15, 2019

Location: Brussels, BE

Company: Terumo BCT, Inc.

Country:  Belgium 

 

JOB TITLE:  QUALITY SYSTEMS SPECIALIST - EMEA

 

JOB SUMMARY

The Quality Systems Specialist function is responsible for:

  • Processing all products quality complaints on disposables, equipment and system performance across the EMEA region
  • Creation 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 EMEA QMS

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

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.


Complaints Processing

  • 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
  • Process 1st time closed reports, generate close out letter, coordinate review and approval with sales representatives, then send to Customer.
  • Archive close out letters and other documents related to complaint processing in complaint database, or other electronic storage location.
  • Produce credit reports for processing by Customer Service and other reports as requested by sales teams
  • Attend meetings, face to face and via conference calls, to review status of complaints with other EMEA QA team members and/or colleagues from CHU
  • Drive the overall complaint process to ensure complaint handling meets the close out criteria KPI

 

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.).

EMEA QMS

  • 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

 

MINIMUM QUALIFICATION REQUIREMENTS

Education

Graduated Administration/Languages/Secretary

Experience

  • 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: ISO9001 or ISO13485
  • 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

ADDITIONAL INFORMATION

  • Based: Brussels Office EMEA
  • Reporting to:  Senior Quality Manager- EMEA
  • May be required to travel domestically and internationally one or two times a year.

Join Terumo BCT as we Unlock the potential of blood.

 

As we strive to make even safer, higher-quality transfusions available to more people, we can unlock the potential of blood and cell therapies. We can help our customers bring even more treatment options to patients through advanced blood therapies. We can support researchers in developing cellular therapies that may fundamentally improve health care. Terumo BCT is guided by our customers' needs, aspirations and ongoing drive to improve efficiency and patient outcomes.

 

Each associate has a positive impact on our future and the lives of the patients we ultimately serve.


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