Profil #249561

Biomedical engineer, bringing experience from medical physics, health IT, and pharmaceutical QA. I specialize in IT compliance, validation, and risk assessments within regulated environments where data integrity and patient safety are paramount. I thrive in roles that bridge technology and people.
Opdateret 13. oktober 2025
Min uddannelse
2014 - 2018

Civilingeniør

Danmarks Tekniske Universitet - DTU

Uddannelsesområde: Medicinal & Sundhed
Periode: august 2014 - november 2018
Min erhvervserfaring
2023 - nu

Advanced QA Professional

Novo Nordisk A/S

Promoted from QA Professional to Advanced QA Professional in a GMP-regulated aseptic production environment. Expanded responsibilities within IT compliance, validation, and strategic QA development.

Key Contributions:
  • QA oversight of GxP-critical systems, equipment, and processes with focus on data integrity, compliance, and audit readiness
  • Review and approval of validation documentation, audit findings, and regulatory responses
  • Planning and execution of risk-based validation strategies (SRV) in close collaboration with system owners
  • Active member of an IT QA process group working on standardization and continuous improvement across Novo Nordisk globally
  • Sparring partner for QA colleagues on compliance, risk assessments, incident flow, and documentation
  • Strengthening QA presence in operations through collaboration with process support, IT operations, and compliance
  • Providing QA input to CAPA proposals and root cause analyses with a critical, independent perspective


    • Core competencies: GxP · ITRA · CAPA · GMP · Risk Assessment · IT Compliance · IT Lifecycle · IT System Validation (CSV) · Data Integrity · Audit Readiness · Stakeholder Engagement · Cross-functional Collaboration · Process Validation · Data Integrity · QA Oversight · Shop Floor QA · Training & Mentoring · Continuous Improvement · Change Management · eQMS · Requirement Specifications · Document Change Control
    Arbejdsområde: Produktion
    Periode: april 2023 - nu
    2020 - 2023

    Application Specialist

    Region Hovedstaden - It, Medico og Telefoni

    Balanced 3rd-level support with participation in an agile SAFe development team for the Danish healthcare platform (SP). This dual role enabled both hands-on troubleshooting and system improvement in close collaboration with product owners and scrum masters.

    Key Contributions:
  • Provided application support and troubleshooting for clinical staff, focusing on usability and system stability
  • Designed and executed regression tests in ALM to validate bug fixes and upgrades
  • Contributed to planning and improving the messaging system via SP’s database modules
  • Collaborated with clinicians, developers, and stakeholders to align solutions with workflows and regulatory frameworks

    • Core competencies: Healthcare IT · MDR · QMS · ALM · Regression Testing · Application Support · Remote Troubleshooting · Clinical Workflows · Stakeholder Engagement · Change Management · Agile · SAFe · Product Owner Collaboration · Scrum Master Collaboration · User Engagement · Compliance
    Arbejdsområde: IT - Software
    Periode: august 2020 - marts 2023
    2019 - 2020

    Medical Physicist (Clinical Engineer with focus on QA and QC)

    Onkologisk Klinik på Rigshospitalet

    Responsible for quality assurance and control of advanced radiotherapy equipment and planning processes—always with patient safety and treatment accuracy at the core.

    Key Contributions:
  • Performed QA/QC of radiotherapy systems using calibration and imaging software
  • Conducted systematic spot checks of patient treatments and resolved discrepancies in close dialogue with radiographers
  • Acted as technical specialist in patient positioning, bridging physics, workflows, and clinical staff
  • Contributed to risk assessments, validation of new medical equipment, audit preparation, and radiation safety training

    • Core competencies: QA/QC · Radiotherapy · MV Imaging · Calibration · Risk Assessment · Medical Equipment Validation Radiation Safety · Clinical Engineering · Patient Safety · Cross-functional Collaboration · Technical Expertise and Authority
    Arbejdsområde: Medicinal & Sundhed
    Periode: januar 2019 - juli 2020
    Mine kompetencer
    Evner
    agile ansvarlig application lifecycle management (alm) bridging technical and business brugerinddragelse brugervenlighed capa cgmp change management change request computer system validation (csv) cross-functional collaboration customer relations deviations document review end-user communication eqms fda fejlfinding fokus på kvalitet i mit arbejde forståelse for kundebehov gmp gxp hoq iderig implementering af nyt udstyr intern audit iov iq/oq iso standarder it compliance it lifecycle it qa it systems itra kendskab til c# kendskab til c++ kendskab til python kundebehovsvurdering latex matlab microsoft office måle metoder nysgerrig pfv pq qa qc qms regulatoriske krav regulatory requirements risikoanalyse risk assessment safe selvstændig problemløser servicenow sharepoint sop stakeholder communication stærke analytiske evner support troubleshooting træning tværfaglig forståelse og samarbejde user requirements (urs)
    Sprog på arbejdsniveau
    dansk engelsk
    Mine præferencer
    Jobtype
    Fuldtidsjob
    Arbejdsområde
    Data & Analyse IT - Software Medicinal & Sundhed Naturvidenskab Teknik Undervisning
    Geografi
    Nordsjælland Storkøbenhavn
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