Experience

Dahlfelt Consulting ApS

• Denmark
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Senior Consultant

  • Mar 2023 - Present



Sigma Connectivity Denmark

• Denmark
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Senior Consultant

  • Apr 2020 - Feb 2023

  Project manager at a medical device manufacturer developing a class II, sterile convenience kit. Overseeing activities from initial user needs and design development planning, risk management and design inputs to choosing of manufacturing strategy, process validation, sterilization validation, design verification/validation. Gap analysis of a QMS system aiming for an ISO 13485 certification for a tech company/design house. Project manager at a medical device manufacturer developing a class II, sterile convenience kit. Overseeing activities from initial user needs and design development planning, risk management and design inputs to choosing of manufacturing strategy, process validation, sterilization validation, design verification/validation. Gap analysis of a QMS system aiming for an ISO 13485 certification for a tech company/design house.



AL Engineering A/S

• Denmark
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Consultant

  • Oct 2012 - Apr 2020

  As a Senior Consultant within the medical device industry I have had the pleasure to work with the major medical device companies that manufacture devices ranging from Class I to Class III in the Copenhagen area and abroad. The durations of these contracts have ranged from a few months to 2,5 years with returning clients. The assignments include the following working areas: • Qualification of manufacturing equipment – establishment of a user requirements specification and test protocols. Execution of test plans. • Process validation – establishment of test protocols and execution of test plans. • EO sterilization validation – review and approval of protocol and report established by sub contractor. • Test method validation – establishment of test protocol and reporting. • GAP analysis – reporting of gaps between areas of a client’s QMS compared to the ISO 13485/21 CFR Part 820. • QA role responsible for review and approval of design control -, risk management – and usability documentation in a R&D development project. Review and approval of test documentation, change requests and CAPA. Participation in certification audit and supplier audit. • Advisory role regarding design control, process validation and sterilization validation. • Compliance issues with ISO 13485 and 21 CFR Part 820. Show less



Thermo Fisher Scientific

• United States
• Biotechnology Research
• 700 & Above Employee

• Quality Specialist

  • Jan 2008 - Oct 2012

  The role as a Quality specialist and as the person responsible for the quality/compliance aspects of the gamma facility, it has provided me an in-depth knowledge of how such a facility works and hands-on experience with dose mapping issues, validation issues and dosimeter calibration issues. During the years I have managed to implement several initiatives that have lifted the compliance level of the gamma facility. Besides the facility I was also participating in site improvement and lean projects.• Sterilization validation of an in-house gamma facility to comply with ISO 11137 following an annual source replenishment. • Performance of dose mapping of products and reporting. • Performance of calibration of purchased dosimeter batches. • Rev/appr. of daily sterilization reports for release of sterilized products. • Rev/appr. of e-beam/gamma sterilization documentation from sub supplier. • Rev/appr. of sterilization reports for release of sterilized products performed at sterilization sub supplier. • Audit of sterilization supplier. • Participation in certification audit and customer audit. • Compliance projects to ensure that the gamma facility and its processes comply with ISO 11137: o Impl. of max. dose. o Impl. of family groups. o Impl. and standardization of PQ dose mapping for family groups. o Impl. of in-house dosimeter calibration. o Determination of dosimeter uncertainty for use in OQ/PQ. o Impl. of dummy material during OQ, reduction of process variation. o Impl. of differentiated sterilization cycles for sterile vs. non-sterile products that are sterilized for other purposes. o Impl. of barcode system and sterilization batch release by measurement of a ref. dosimeter. • Site improvement and lean projects such as impl. of a vision system for QC and a software system for measurement of dosimeters and release of sterilized goods. • Internal audit. • Handling of CAPA, complaints and change requests. Show less

• Irradiation technician

  • Jun 2007 - Dec 2007

  As an Irradiation technician the responsibilities have been mainly about the daily operations of the gamma facility and the sterilization validation following the annual gamma source replenishment. The key responsibilities as a Irradiation technician:• Sterilization validation of an in-house gamma facility to comply with ISO 11137 following an annual source replenishment.• Performance of dose mapping of products and reporting.• Review and approval of daily sterilization reports for release of sterilized products.• Review and approval of e-beam/gamma sterilization documentation from sub supplier. • Review and approval of sterilization reports for release of sterilized products performed at sterilization sub supplier. Show less