Harald Ottedag Email & Phone Number

Malmö, Se

Lund, Skåne County, Sweden

Having advanced from a Test Engineer at CellaVision to a Quality Specialist at Radiometer, I am now utilizing my experience in the Medtech industry as a Quality Consultant at Additude. My understanding of quality assurance, control, verification and validation, and regulatory compliance enables me to help medical technology companies enhance the quality of their products and processes.This year, I successfully led a software project using the Scrum framework, which culminated in the… Show more Having advanced from a Test Engineer at CellaVision to a Quality Specialist at Radiometer, I am now utilizing my experience in the Medtech industry as a Quality Consultant at Additude. My understanding of quality assurance, control, verification and validation, and regulatory compliance enables me to help medical technology companies enhance the quality of their products and processes.This year, I successfully led a software project using the Scrum framework, which culminated in the development of a CV web application. This internal project not only sharpened my project management skills but also reinforced my capabilities in leading cross-functional teams to deliver high-quality software solutions.As a consultant, I offer the following:- Provide advice on establishing and optimizing quality systems to ensure compliance with industry and regulatory standards for medical devices.- Conduct reviews of existing quality systems and processes, identifying areas for improvement.- Lead and perform testing, software and hardware.- Offer guidance on the documentation of design changes, risk assessments, and test data to maintain traceability and regulatory compliance. Show less

Copenhagen, Capital Region, Denmark

I started as a Test Leader, leading a stability study on the accessories of the ABL90 blood analysis device. This project was part of our transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR), ensuring compliance with the new standards. After completing this key verification, I moved into quality control. My focus shifted to developing and enhancing the Quality Management System (QMS), particularly fascinated by structuring requirements and managing change… Show more I started as a Test Leader, leading a stability study on the accessories of the ABL90 blood analysis device. This project was part of our transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR), ensuring compliance with the new standards. After completing this key verification, I moved into quality control. My focus shifted to developing and enhancing the Quality Management System (QMS), particularly fascinated by structuring requirements and managing change requests.Responsibilities:- Led the stability study for ABL90 device accessories, coordinating the efforts of a team of lab technicians.- Conducted both hardware and later software validations to comply with MDR requirements.- Authored protocols and reports, utilizing tools like JMP for data analysis to support compliance and documentation.- Managed UDI compliance to ensure accurate product labelling and database entries for global traceability.- Streamlined and improved the QMS by focusing on efficient structuring of requirements and effective handling of change requests. Show less

Lund, Sweden

At CellaVision, I worked as a Test Engineer where I played a key role in the verification and validation of medical devices utilizing advanced image recognition AI for blood analysis. My efforts were pivotal in ensuring that both hardware and software components met the stringent standards required by the EU's Medical Device Regulation (MDR) and the U.S. Food and Drug Administration (FDA). This position not only honed my technical skills but also deepened my interest in quality assurance and… Show more At CellaVision, I worked as a Test Engineer where I played a key role in the verification and validation of medical devices utilizing advanced image recognition AI for blood analysis. My efforts were pivotal in ensuring that both hardware and software components met the stringent standards required by the EU's Medical Device Regulation (MDR) and the U.S. Food and Drug Administration (FDA). This position not only honed my technical skills but also deepened my interest in quality assurance and regulatory compliance.Responsibilities:- Contributed to validation and verification testing for functionality expansion to animal blood analysis.- Edited and updated technical manuals to comply with regulatory requirements.- Performed data analysis to support and verify test outcomes.- Documented testing processes and results to ensure regulatory compliance.- Worked as part of a SCRUM team. Show less

Gothenburg, Vastra Gotaland County, Sweden

As a private tutor and mentor for ages 12-18, I have had the privilege of working with students from diverse backgrounds and abilities over a period of 3 years. I was dedicated to helping each student achieve their academic goals, as well as fostering their personal growth and development.My approach to tutoring was rooted in building a strong foundation of mathematical knowledge while promoting critical thinking, problem-solving skills, and confidence. I provided personalized… Show more As a private tutor and mentor for ages 12-18, I have had the privilege of working with students from diverse backgrounds and abilities over a period of 3 years. I was dedicated to helping each student achieve their academic goals, as well as fostering their personal growth and development.My approach to tutoring was rooted in building a strong foundation of mathematical knowledge while promoting critical thinking, problem-solving skills, and confidence. I provided personalized instruction tailored to meet the unique needs and learning styles of each student, utilizing a variety of teaching methods and resources to support their success.As a mentor, I also prioritized building positive relationships with my students, providing guidance, and support beyond academic instruction. I worked to cultivate a safe and supportive learning environment where students feel comfortable asking questions and seeking help, while also empowering them to take ownership of and lead in their school experience.Throughout my tenure, I saw tremendous growth and progress in my students, both academically and personally. I was a rewarding experience and I would like to be in a mentoring and teaching position again in the future. Show less

Gothenburg, Vastra Gotaland County, Sweden

During tenure as a substitute mathematics teacher for ages 15-18, I navigated the challenges of classroom discipline through a mix of inspiration, direct engagement, and necessary firmness. This approach not only maintained order but also fostered an environment conducive to learning and personal growth.My teaching methodology combined traditional presentations with interactive, workshop-style sessions. These workshops encouraged students to actively engage with the material, enhancing… Show more During tenure as a substitute mathematics teacher for ages 15-18, I navigated the challenges of classroom discipline through a mix of inspiration, direct engagement, and necessary firmness. This approach not only maintained order but also fostered an environment conducive to learning and personal growth.My teaching methodology combined traditional presentations with interactive, workshop-style sessions. These workshops encouraged students to actively engage with the material, enhancing their critical thinking and problem-solving skills. I prioritized creating a supportive and inclusive classroom atmosphere, ensuring all students felt comfortable participating in discussions and collaborative exercises. Show less

Master'S Degree, Physics

Bachelor'S Degree, Chemical Engineering

High School Diploma