Quality Assurance and Regulatory Affairs

ID1031

QMS & Supplier Quality Expert

Zealand Business College
Available for: Full time, part time, tasks

Competences

  • Supplier Management.

  • Quality Management.

  • Audit Management.

  • Trained lead auditor/internal auditor.

  • Team/Department management.

  • Management representative.

  • 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 she was interim QA Manager.

Software/Standards

Extensive knowledge in:

  • ISO9001 (Lead Auditor)

  • ISO13485

  • MDSAP

  • Medical device regulation 2017/245 (Internal Auditor)

Knowledge in:

  • In vitro diagnostic medical devices 2017/246
  • FDA 21 CFR part 820

Software skills:

  • SAP QM Key user
  • Documentum Key user
  • TrackWise
  • Agile
  • D4
  • 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