
Vibeke Damgaard Nielsen

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About me
Quality Manager, Special Feed -Vilomix
Education

Holstebro Tekniske Skole
1996 - 1998LaborantAnalyser og apparatteknikBeregning og valideringKemi med anvendt matematik

Aarhus Universitet
2019 - 2020HD 2. del Organization and Management
Danmarks Tekniske Universitet
1999 - 2003LevnedsmiddelingeniørKvalitetsledelse og virksomhedsøkonomiFødevaresikkerhed og lovgivningBiokemi, anatomi, human fysiologi og ernæringIndustrielle enhedsoperationer og procesteknologi

Erhvervsakademi Dania
2011 - 2011OrganisationLedelse og organisationsdesignOrganisationsudviklingTeamledelse og sammensætning af teams
Experience

Arla Foods Ingredients
Sept 2003 - Feb 2008- Responsible for development, pilot planning and implementation of new products for commercial production in accordance with applicable legislation as well as customer requirements. - Full project manager responsibility for own projects ranging from idea to finished product is implemented in production and documentation is in place. - Close collaboration with international pharmaceutical clients, internal sales and procurement, external suppliers, laboratories and production. - Responsible for building and developing validation / qualification documentation, including planning and implementation of validation / qualification projects (DQ / IQ / OQ / PQ)- Responsible for development, implementation and management of the factory's change control system.- Close cooperation with international customers, contact to authorities and certification bodies, production engineering department and production sections at the factory.
Product Application Specialist
Nov 2005 - Feb 2008QA Specialist
Sept 2003 - Nov 2005

Zone Denmark
Feb 2008 - Sept 2011QA | Compliance Manager- Developed and implemented Quality Management System including test verification and product compliance (able to meet requirements from the export market as well as Danish and European legislation) - Daily management in DK and China- Collaboration with external designers, OEM partners and manufacturers. - Close cooperation with certification bodies and contact with authorities. • Change management and coaching• Design and Trademark Registration (IPR)• Preparation of certificates and legislation• Corporate Social Responsibility (CSR)• Total Quality Management System• REACH Chemicals Directive• Cosmetic legislation Show less

BESTSELLER
Sept 2011 - Jan 2019- Daily management of global audit programme - CSR and Compliance data reports- Management of supplier portal - Gouvernance and quality in supplier and compliance data - IT development - Define conceptual strategy- Develop and implement the controlled process for the concept- Power Measurements- Change and project management
CSR | Audit Program Manager
Jan 2013 - Jan 2019Process Specialist
Sept 2011 - Sept 2013

Etac Group
Aug 2020 - Mar 2024Quality & Compliance Manager, Patient HandlingAs Quality & Compliance Manager I am member of the cross-functional management team, which include development and improvement of business results through strategic development and decision making for execution on agreed actions and to secure compliance and conformity with relevant regulations, directives and standards set forth as needed business strategies.I am also appointed as the PRRC (Person Responsible for Regulatory Compliance) and has the process ownership of Post Market Surveillance, regulatory reporting, investigation of incidents, communication with authorities, data submission and product registration activities. Show less

Vilomix Group
Apr 2024 - nowQuality ManagerAs Quality Manager for Special Feed I am overall responsible for the quality management in Vilomix, compliance with international regulations, licenses and certifications. Translate strategic decisions into actions and goals for all Vilomix units globally and close collaboration with local QA Managers when quality activities are planned and implemented.Main responsibilities cover areas like:• Overall responsibility for product compliance with regulatory and customer requirements• Develop and maintain a global quality strategy, ensuring efficient use of the quality management system and processes• Communication, facilitation and implementation of quality strategy at all levels and locations• Support and guidance for local quality people• Maintain required certifications and standards Show less
Licenses & Certifications

ISO90001
TQM, Vejle
ISO13485 internal auditor
Bureau Veritas GroupJun 2023
Medical device post market surveillance
Key2Compliance®May 2022
QA/RA leader medical devices
Key2Compliance®Dec 2021
Volunteer Experience
Stævneleder
Issued by Fjends Herreds Rideklub on Jan 2004
Associated with Vibeke Damgaard Nielsen
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