Melanie Bernt Johnsen

Melanie Bernt Johnsen has a diverse range of work experience. Melanie is currently working at Dawn Health as a Senior QA Professional, where they are responsible for Quality Management System (QMS) compliance and governance. Their tasks include managing nonconformities and CAPAs, conducting internal and external audits, and overseeing document management and control. Melanie also provides consulting services for QMS activities of customers and partners.

Prior to their current role, Melanie worked at Dawn Health as a QA Professional, where they focused on QMS governance and compliance with ISO 13485. Melanie managed non-conformities and CAPAs, coordinated the Change Control process, and facilitated management reviews and audit activities. Melanie also served as a Project Manager for GxP/MDSW projects and provided consultancy on Quality Management activities.

Melanie took a break from their career for maternity leave in 2020, during which they acquired additional skills such as prioritization, decision making, time management, and active listening. Melanie also utilized their time to enhance their hard skills by completing their Academy Profession Degree in Production and taking online courses.

Before their maternity leave, Melanie worked at Abacus Medicine. Melanie started as an Assistant for Optimization & Workflow Analysis, where they contributed to establishing a new department focused on integrating lean thinking into the company's DNA. Their responsibilities included establishing a governance structure, analyzing optimization proposals, conducting process interviews, and facilitating Kaizen Blitz workshops. Melanie achieved significant results in this position, including assisting with a production process improvement workshop that led to reduced cycle time and financial savings.

At Abacus Medicine, Melanie also served as a Quality Assurance Officer and Assistant of Purchase and Supply Chain (QA). Additionally, they gained experience as a Studenthelper in the Finance department.

Overall, Melanie Bernt Johnsen has demonstrated their expertise in Quality Management, consultancy, project management, and process improvement throughout their career.

Melanie Bernt Johnsen's education history is as follows:

From 2019 to 2021, they attended the Copenhagen Business Academy and obtained an Academy Profession Graduate in Innovation, Product & Production. Their field of study was production.

In 2021, they completed a webinar titled "Sådan styrker I Jeres feedbackkultur" at Feedwork.

In 2019, they took a course titled "Når ledelse er kommunikation" with Leif Pjetursson at DTU - Technical University of Denmark.

In 2017, they completed a supplementary course in Chemistry B at VUF.

In 2016, they completed two supplementary courses at KVUC, one in Mathematics A and the other in Physics B.

From 2013 to 2016, they attended Ørestad Gymnasium and obtained an STX degree with a field of study in psychology.

From 2021 to 2023, they are currently pursuing a Diploma of Leadership at the Copenhagen Business Academy.

In addition to their education, Melanie has obtained several certifications. In 2023, they obtained the MDSAP Fundamentals and Readiness certification from BSI. In 2022, they obtained certifications in Introduction to Software for Medical Devices and IEC 62304 from Medical Device HQ, and MDD to MDR Transition from Medicoindustrien. In 2021, they obtained certifications in Managing Generation Z from LinkedIn, and Introduction to the Medical Device Industry and Measuring Learning Effectiveness, both from Medical Device HQ. In 2021, they also obtained Six Sigma Foundations and Statistics Foundations: 1 certifications from LinkedIn. Prior to that, in 2019, they obtained the GMP certification from Pharmakon. In 2018, they obtained the GDP II certification, and in 2017, they obtained the GDP I certification, both from Pharmakon.