Olli Mikkonen

Olli Mikkonen Email and Phone Number

Director of Quality and Regulatory Affairs at Blueprint Genetics @ Blueprint Genetics
helsinki, uusimaa, finland
Olli Mikkonen's Location
Finland, Finland
Olli Mikkonen's Contact Details

Olli Mikkonen personal email

n/a
About Olli Mikkonen

• Working with quality management at Blueprint Genetics• Focusing on regulatory compliance, organizational excellence and quality as competitive advantage• Passionate about organizational learning and communication• Background in medical device industry• In my work, I get inspired from continuous improvement and when I get to learn something new every day

Olli Mikkonen's Current Company Details
Blueprint Genetics

Blueprint Genetics

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Director of Quality and Regulatory Affairs at Blueprint Genetics
helsinki, uusimaa, finland
Website:
blueprintgenetics.com
Employees:
171
Olli Mikkonen Work Experience Details
  • Blueprint Genetics
    Director Of Quality And Regulatory Affairs
    Blueprint Genetics Sep 2021 - Present
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  • Blueprint Genetics
    Quality Manager
    Blueprint Genetics Nov 2017 - Oct 2021
    - Leading and managing the Quality Management Team- Responsible for CLIA certified, CAP and ISO 15189 accredited Quality Management System- Continuous improver of regulation and compliance strategy
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  • Abacus Diagnostica Oy
    Quality Manager
    Abacus Diagnostica Oy Oct 2014 - Nov 2017
    - responsible for the management of ISO 9001 & ISO 13485 + CMDCAS certified quality system- responsible for audits- responsible for product registrations
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  • Abacus Diagnostica Oy
    R&D Manager
    Abacus Diagnostica Oy Sep 2011 - Nov 2017
    Team management of R&D project group, project management of IVD test development for the GenomEra CDX platform (PCR), including planning and designing IVD tests according to ISO 13485, risk management activities (ISO 14971) and regulatory requirements of EU IVDD and Canada CMDR.Experience on projects funded by EU and the Finnish Funding Agency for Technology and Innovation (TEKES).
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  • Abacus Diagnostica Oy
    R&D Chemist
    Abacus Diagnostica Oy Sep 2009 - Aug 2011
    Finland
    Organizing daily R&D activities, experiment planning and designing.
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  • Abacus Diagnostica Oy
    Research Assistant
    Abacus Diagnostica Oy Dec 2008 - Aug 2009
    Oligonucleotide labelling especially with lanthanide chelates, HPLC purification of oligonucleotides, spectrometric measurements and general laboratory work including PCR based techniques.
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Olli Mikkonen Skills

Quality Management Project Management Iso 13485 Iso 9000 Molecular Diagnostics Assay Development Regulatory Affairs In Vitro Diagnostics Nucleic Acid Extraction Nucleic Acid Amplification Internal Audit Regulatory Requirements Pcr Rt Pcr Ivd Biotechnology Life Sciences Molecular Biology Quality System Regulatory Compliance Medical Devices Business Process Improvement

Olli Mikkonen Education Details

Frequently Asked Questions about Olli Mikkonen

What company does Olli Mikkonen work for?

Olli Mikkonen works for Blueprint Genetics

What is Olli Mikkonen's role at the current company?

Olli Mikkonen's current role is Director of Quality and Regulatory Affairs at Blueprint Genetics.

What is Olli Mikkonen's email address?

Olli Mikkonen's email address is ol****@****ica.com

What schools did Olli Mikkonen attend?

Olli Mikkonen attended Turun Yliopisto, Turun Yliopisto, Tampere University Of Technology.

What skills is Olli Mikkonen known for?

Olli Mikkonen has skills like Quality Management, Project Management, Iso 13485, Iso 9000, Molecular Diagnostics, Assay Development, Regulatory Affairs, In Vitro Diagnostics, Nucleic Acid Extraction, Nucleic Acid Amplification, Internal Audit, Regulatory Requirements.

Who are Olli Mikkonen's colleagues?

Olli Mikkonen's colleagues are Emma Mårtensson, Uxia Saraiva Esperón Moldes, Ella Varjus, Miikka Antikainen, Matias Rantanen, Aleksandr Poutanen, Terhi Ahvenainen.

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