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Motmans & Partners

Quality Assurance Officer IVD/Medical Devices

Published on Jobat.be 7 days ago

Quality Assurance Officer IVD/Medical Devices

Tosoh Corporation is part of a Japanese chemical and specialty products and materials group that comprises over 130 companies worldwide and a multiethnic workforce of more than 12,000 people. Tosoh Europe N.V is a biotechnology-oriented research company which fulfills the role of marketing Tosoh’s clinical diagnostic systems and related products such as diagnostic reagents. These self-developed and highly technological instruments are sold and distributed to the medical sector through the various sales agencies across Europe. Tosoh therefore offers a strong customer service and customer support to their customers. From the headquarters in Tessenderlo all customer related activities across the EMEA area are supported and optimized. In light of their further growth and professionalization we are looking for a Quality Assurance Officer IVD/Medical Devices.

Job description

Main Responsibilities

In this role you are responsible for the maintenance and improvement of a robust Quality Management System (QMS) consistent with ISO 9001 and ISO 13485. You will work closely with other departments providing QA support and guidance to operational activities, ensuring that all customer and regulatory requirements are met.

  • Management of quality tasks including change control, batch release and process validation
  • Participate in quality related investigations to resolve production, audit, and customer issues
  • Creation, approval, and maintenance of Standard Operating Procedures (SOP) and ongoing management of the Document Control System
  • Organize and facilitate product and process risk assessments
  • Provide training and support to other departments on procedures and core processes
  • Report and follow up on quality key performance indicators in a timely manner
  • Administer the electronic document management system
  • Execute internal and supplier audits and support external audits
  • Ensure all applicable standards are met in relation to regulatory and customer requirements
  • Identify and support quality process improvements
  • Report to the Quality Assurance & Regulatory Affairs Manager

Profile

Profile 

  • Bachelor or Master degree in Science, Biology or Chemistry degree or equivalent
  • 3 years of experience as a Quality Assurance Officer in a manufacturing environment, preferably in in-vitro diagnostics
  • Excellent English (French, Dutch, and/or German language is an asset)
  • Knowledge and practical application of Quality Management System ISO 13485, IVDD 98/79/EC, and In-Vitro Diagnostics Regulation (EU) 2017/746? is a plus
  • Advanced critical thinking and organizing skills
  • Willingness to travel <10% to the Belgium HQ in Tessenderlo

Offer

Offer

  • An exciting position, an international context, an attractive salary package, learning & development opportunities
  • Be part of a great team and a company with an energetic work atmosphere
  • The ability to work from home
  • Work autonomously and directly contribute to customer satisfaction and business success
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    33 days left to apply

    Characteristics

    Requirements

    • Professional bachelor (Higher Education Short Type)
    • At least 2 years experience
    • English

    Offer

    • Permanent
    • Full-time

    Apply before

    • 16 May

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