Years of experience: 36

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Johannes's Career Path
Interim Manage AQTIS staff Class III device, Supplier Controls, CAPA resolution, Change ManagementSep. 2020 -
Dec. 2020
SinclairInterim Manage AQTIS staff Class III device, Supplier Controls, CAPA resolution, Change Management
The Randstad, NetherlandsNice to work with Motivated staff in a Booming company, really enjoyed sharing experience and improving processes in cooperation using what is present. Started a journey on improving supplier controls, CAPA resolution, and Change management. Where I am confident the crew will maintain and improve the processes. Grateful for the Opportunity working with this staff on a Class III device.
QUOIUMAug. 2020 -
Present
QUOIUMQUOIUM
NetherlandsQUOIUM® is specialised in tailored Quality Management Systems for the Medical Device Industry, by its Core documents. Haveitmade Companies is participating in QUOIUM
Principal Consultant, Quality and Regulatory AffairsMay. 2020 -
Sep. 2022
Oriel STAT A MATRIXPrincipal Consultant, Quality and Regulatory Affairs
EuropeOriel STAT A MATRIX provides life sciences organizations with consulting, training, and audit support to achieve compliance with US FDA and global regulations like EU MDR and EU IVDR. Core Values: Happy Employees Do Great Work for Customers Doing the Right Thing for Mutual Success Diversity is a Competitive Advantage Take the Long View Give Back to the Community Looking Forward on Sharing Exp...

Johannes's Posts

  • About

    Key Skills & Achievements: - Expertise in compliance for low-risk devices - Focus on EU MDR and ISO 13485 standards - Trusted by leading Indian certification bodies - Ensures proactive compliance readiness

  • Cases & Experiences

    Case Studies: - Over 25 re-certifications in EU - Management systems for small to medium enterprises - 50+ audits for manufacturers and suppliers

  • Work Order

    Our Certification Services: - Full certification for low-risk devices - Build certification dossier - Onsite audits & document reviews - Continuous surveillance & recertification

  • How to contact

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