Melanie Museth Fogh Email & Phone Number

Copenhagen, Dk

København, Hovedstaden, Danmark

Responsible for maintenance of our ISO 13485, MDSAP and ISO 27001 certified QMS, professional and personal development of Sr. and Jr. QA Professionals, and assisting the Dawn Health organization on quality and compliance matters.Acting as Delegate Management Representative.Overall responsible for compliance across the entire company, as well as our QMS processes (including auditing, CAPA/NC, change orders, documentation, training, management review).

Quality Management System and compliance governance incl. nonconformance and CAPA management, internal and external auditing, preparation, hosting and follow-up on management reviews, document management and control, onboarding, training etc. Consultancy for QMS activities of customers and partners. Acting as supporting management representative for ISO 13485 and MDSAP.Leadership, management and mentoring of Jr. QA Professionals and QA Professionals.Member of Dansk Standard standardization committee for Medical Device Quality Management, S-257.

København, Hovedstaden, Danmark

QMS Governance and Compliance with ISO 13485. Process responsible for management of non-conformities and CAPAs, Change Control process, document management, management review and audit activities. Consultancy and Project Manager of GxP/MDSW projects and Quality Management activties.

I participated in a project to establish a new department in our Copenhagen Office with the scope to integrate lean thinking into the company DNA. Amongst others, my tasks consisted of:• Establishing a governance structure• Prioritizing and analyzing incoming optimization proposals• Conducting process interviews with department managers• Facilitating Kaizen Blitz workshopsGreatest accomplishments in this position include assisting the lead facilitator on a production process improvement workshop, that resulted in a significant reduction in down-stream process cycle time creating potential for financial savings. Tasks from theKaizen Blitz workshop were carried out by colleagues within eight weeks from initiation.

Region Hovedstaden, Danmark

Quality Assurance Officer in Global QA Team and Delegate Responsible Person. Main tasks:• Review and approval of Deviations, Change Controls, and CAPAs• Review and approval of SOPs• Responsible for internal and external audit programme(internal, CMOs, suppliers and transporters)• Lead auditor and audit trainer• Participant on (inter)national inspections• Recall management• Member of the Quality Forum with Quality Top Management• Training of employees (EU cGxP)Further I was responsible for• Preparation and hosting of bi-annual Quality Management Review• Implementation of eQMS – TrackWise across nine sites making quality processes easy-to-access and creating foundation for quality KPIs and measuring of these• Development and implementation of an online SharePoint based training system

Region Hovedstaden, Danmark

- Overview and Monitoring of Debitors and Creditors- Preperations of Meetings with Suppliers- Analysis of Price Requests- Planning of and Participation in Exhibitions - Assisting with QA tasks including audits, incoming products control, deviations and CAPA management

Region Hovedstaden, Danmark

Assisting the finance department in VAT accounts, archiving of tax documents as well as assisting in financial audits.Further:• Planning and participation in Pharma EXPO in Munich andDüsseldorf in 2015 and 2016• Planning and hosting of Friday Bars• Planning and hosting of DHL run in 2015 and 2016• Assisting with QA tasks including audits, incoming products control, deviations and CAPA management

Academy Profession Graduate In Innovation, Product & Production, Production, Average 11,2

Applied Economics - 12/A Organizational Theory - 12/A Production Optimization - 12/A Quality Management in Practice - 12/A Project.

Webinar, “Sådan Styrker I Jeres Feedbackkultur”

Kursus, “Når Ledelse Er Kommunikation” M. Leif Pjetursson

Supplememtary Course, Chemistry B, 12

Supplememtary Course, Matematics A, 10 (Written), 7 (Oral)

Supplementary Course, Physics B, 10

Stx, Psychology, 10,9

Level A: Danish, History, Spanish and English Level B: Biology, Psychology, Social Studies, Mathematics

Diploma Of Leadership, Average 9,82

Organization, Culture and Change Management - 12/A Personal Leadership and Change - 10/B Project Management - Merit Leadership.