Mirka Oksman

Experience

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  Eimo Oyj

  May 1999 - Sept 2002

  Quality Engineering

  Working in injection molding company related to telecommunication business. Responsible among others production/product quality, new product implementation to production, mould approvals, process development and visual quality in paint shop. Participating customer audits as a member of team.Quality tools such as SPC, FMEA, Contorl Plan and Flow Chart were used daily.

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  Saloplast

  Jan 2002 - Jan 2004

  Quality Engineer

  Working in injection molding company related to telecommunication business. Responsible among others production/product quality, new product implementation to production, process development and visual quality in paint shop. Participating customer audits as a resposible person.Working as a supervisor of quality persons in shifts. Quality tools such as SPC, FMEA, Contorl Plan and Flow Chart were used daily.Finalizing six sigma black belt project related to usage of the recycled raw material in injection molding. Show less

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  Nypro CMS Oy (former Saloplast)

  Sept 2002 - Feb 2005

  Quality Engineer

  Working in injection molding company related to telecommunication business. Responsible among others production/product quality, new product implementation to production, process development and visual quality in paint shop.Participating customer audits as a resposible person.Working as a supervisor of quality persons in shifts.Quality tools such as SPC, FMEA, Contorl Plan and Flow Chart were used daily.Finalizing six sigma black belt project related to usage of the recycled raw material in injection molding. Show less

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  Odda Plast

  May 2005 - Aug 2005

  Quality Engineer

  Updating quality manual from ISO 9001/94 to ISO 9001/2000

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  GE Healthcare

  Sept 2005 - Apr 2014

  In the Supplier Quality Engineer role being responsible for coordinating supplier quality in accordance with the requirements of GE Healthcare and quality standards as ISO 1348 and FDA QSR. Conducting regular supplier audits to ensure compliance with regulatory standards, as well as actively participating in strategic development based on quality control plans. Managing the supply chain, serve as the liaison for suppliers, suggest structural quality and process improvements, and collaborate with other engineers.Identify technical problems with suppliers and implement corrective actions and increase quality reliability. Maintaining accurate quality records, certifications, and database screens. Conducting capability assessments that verify supplier qualifications, travel to assigned suppliers, and participare transfers as a team member. Participating in preparational actions related to the FDA audit and participaring FDA audit as a team member in back room. Show less In the Complaint Leader role being responsible of handling global complaints related to patien monitors and modules.Role included identification of the safety or potentially safety related complaints and managing those complaints according to regulatory requirements. Conducting Medical Device Reporting (MDR) decissions, managing risk assesments related to safety complaints.Taking care of complaint investigation with engineering. Subject Matter Expert September 2006Through SME role managing and further developing the complaint process, training staff, developed a complaint handling routines.5 weeks assignment in GE Healthcare Utah facility relaed to complaint handling, May 2007Participating internal audits as auditee and in external audits as responsible person. Participating in preparational actions related to the FDA audit. Show less

  • Supplier Quality Lead Engineer

    Sept 2009 - Apr 2014

  • Complaint Leader

    Sept 2005 - Sept 2009
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  Plastone Oy

  Apr 2014 - Aug 2015

  Quality Manager

  Acting as a Quality Manager and member of management team. When working in Plastone I was responsible of the adequacy and effectiveness of the quality management system. I remodeled the standard operating procedures to better respond customer needs.

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  Scanfil Oyj

  Aug 2015 - Jun 2017

  When acting in global role I was a team member of two demanding production transfer project and in my responsibility were all quality related issues by creating detailed quality plan that was executed. I was also taking care of customer communication related to quality issues. During the transfer I build and implemented the ISO 13485 quality management system to one of the factories. End of the project factory was ISO 13485 certified. Main responsibilities: - Participate to the development actions to improve and maintenance the QMS. Participated demanding customer audit and managed adequate and effective responses to audit findings on time.- Lead improvement meetings and drive CAPA actions- Lead internal improvement projects- Execute actions related NPI projects such as DFMEA, Flow Chat and Control Plan.- Completed FDA QSR training

  • Manager, Global Quality Systems (ISO 13485, ISO 9001)

    Aug 2016 - Jun 2017

  • Quality Engineer

    Aug 2015 - Aug 2016
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  Thermo Fisher Scientific

  Jun 2017 - Aug 2021

  QA Engineer, Thermo Fisher

  Prepared actions related to FDA, MD SAP, ISO 13485, ISO 9001 audits by reviewing documents, records and SOP’s.In a demanding new product development project responsible of product quality and compliance (ISO 9001, ISO 13485). Conducted several process validations internal and external. Responsible of quality actions related to manufacturing (internal and external)Lead supplier audits and development actionsLeading production corrective action meetings

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  Instru Optiikka Oy

  Aug 2021 - Nov 2022

  Quality and Development Manager
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  Hologic, Inc.

  Oct 2022 - Apr 2024

  Quality Assurance Manager
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  Fepod Oy Ltd

  May 2024 - now

  Quality & Regulatory Manager