ID1031
QMS & Supplier Quality Expert
Zealand Business College
Available for: Full time, part time, tasks
Contact us for full CV
Competences
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Supplier Management.
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Quality Management.
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Audit Management.
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Trained lead auditor/internal auditor.
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Team/Department management.
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Management representative.
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Quality system implementation.
Key results
Have held titles as QC team manager, Supplier Quality manager, QMS manager and Head of QA.
Holding these titles, the companies have gotten certified or re-certified according to ISO9001, ISO13485, MDSAP, GMP+ and FSSC22000.
Assisted consultant customer in achieving recertification according to ISO13485 and obtaining IVDR certification while I was interim QA Manager.
Software/Standards
Extensive knowledge in:
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ISO9001 (Lead Auditor)
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ISO13485
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MDSAP
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Medical device regulation 2017/245 (Internal Auditor)
Knowledge in:
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In vitro diagnostic medical devices 2017/246
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FDA 21 CFR part 820
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ICH guidelines
Software skills:
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SAP QM Key user
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Documentum Key user
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TrackWise
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D4 Key user
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Agile
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MS Office
Personal Characteristics
Helps to create team spirit.
Appreciates presence and equality.
Looks at the company with a holistic view, as all joints are needed to make the wheels turn.
In her spare time she spends time with family and friends, walks her two dogs, rides her bike or enjoy the family house in Sweden.
Contact
Medicologic A/S
Arne Jacobsens Alle 15-17
DK-2300 København S
Denmark
(+45) 48 24 51 13
contact@medicologic.com
Medicologic-profile
Where to find us
Michael Funder
Owner / Director
(+45) 20 64 41 46
mf@medicologic.com
Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05
lba@medicologic.com