Profilbillede af clearcutwritings
@clearcutwritings
Flag for Ireland Tipperay, Ireland
Medlem siden 27. november 2017
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clearcutwritings

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I have worked in the medical device industry for 15 years in quality, regulatory & risk management roles. My areas of expertise include:  Creation of QMS documentation to comply with ISO13485 & ISO9001  Risk management for the medical device industry  EU MDR2017/745 requirements & gap analysis  QMS review to determine level of compliance with ISO13485 & ISO9001  Remote internal & supplier auditing
$40 USD/hr
18 anmeldelser
4.4
  • 95%Jobs udført
  • 93%Indenfor Budget
  • 94%Til Tiden
  • 46%Genansættelsesfrekvens

Portfolio

Nylige bedømmelser

Erfaring

Remote QMS & RA Consultant

Jul 2017

Establishment of my own business providing remote QMS and RA support to the medical device and high precision engineering industries

QMS/Risk Management Official

Jan 2015 - Jun 2017 (2 years)

Responsibilities included: - Documentation (authoring and approval of technical documentation) - Quality systems activities (CAPA, NC, complaints, internal/supplier auditing, regulatory body audits) - Risk management activities

Quality Systems Engineer

Apr 2007 - Mar 2014 (6 years)

Responsibilities included: - Documentation (authoring and approval of technical documentation) - CAPA - Non-conformances - Supplier auditing - Internal auditing - Facilitating regulatory body audits

Sterilization & Microbiology Technician

Sep 2005 - Dec 2006 (1 year)

Responsibilities included: - Authoring of sterilization validation protocols and reports - Review and approval of routine sterilization batch records - Microbiological testing of product

Uddannelse

Bachelor of Science (Hons) Degree - Industrial Microbiology

1999 - 2003 (4 years)

Kvalifikationer

Medical Device Risk Management (2018)

ASQ (American Society for Quality)

EU MDR 2017/745 (2018)

BSI (British Standards Institution)

ISO19011:2018 - Auditing Management Systems (2018)

Exemplar Global

Virtual Communication & Remote Auditing Techniques (2018)

ASQ (American Society for Quality)

ISO9001:2015 Lead Auditor (2018)

Exemplar Global

Professional Technical Writing (2017)

Carleton University

ISO13485:2016 - Lead Auditor (2016)

IQC (Irish Quality Centre)

Certificeringer

  • UK English 1
    87%
  • US English Level 1
    87%
  • Numeracy 1
    83%

Verifikationer

  • Facebook forbundet
  • Foretrukken Freelancer
  • Betalingsverificeret
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  • E-mailverificeret

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