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Job Details

Senior QA Specialist - Dublin

Company: Hobson Prior
Location: Dublin
Reference: MO476097
Closing Date: 21 Mar 18
Type: Contract
Salary (£): On Application
Benefits: Dependent on Experience

Job Summary:

To provide Quality and Regulatory Compliance support for Medical Devices and In-Vitro Diagnostics primarily within the EU.


Primary Role:

  • To provide Quality and Regulatory Compliance support for Medical Devices and In-Vitro Diagnostics primarily within the EU.


  • Maintain compliance of Shire Global Quality Standards against changing device and IVD regulations in particular the EU MDR and IVDR and associated legislation. 
  • Coordinate management reviews, post market surveillance, DHF audits and independent design reviews as required.
  • Support maintenance of product compliance to CE marking requirements.
  • Support EU medical device complaints including vigilance assessments.
  • Support day to day product quality including deviation and CAPA resolution, CMO management including supplier notifications of change and supplier corrective action reports and change controls.
  • Internal and external audit support including site readiness.

Education & Experience Requirements:

  • University degree or equivalent in Science, Engineering or an equivalent technical discipline – required
  • At least 5 years’ experience in a Quality role working with medical device/in-vitro diagnostics/ combination products in a regulated healthcare industry – required
  • Good understanding of E.U., U.S. and international medical device regulations and standards including ISO 13485, ISO 14971, E.U. Medical Device  and In-Vitro Diagnostic Directive (MDD & IVDD), E.U. Medical Device and In-Vitro Diagnostic Regulations (MDR & IVDR) and relevant CFRs – required
  • Experience with deviations, non-conformances, CAPA and change control - required
  • Experience with SAP, Trackwise or similar systems – required
  • Prior experience in a  compliance role - preferred

Key Skills and Competencies:

  • Excellent attention to detail
  • Strong time management skills and the ability to prioritise activities
  • Excellent verbal and written skills
  • Good analytical and problem solving skills
  • Strong decision making skills

In addtion:

  • Coordinate activities with SMEs across multiple time zones
  • Escalation of potential device vigilance issues to Device Quality Assurance Lead.
  • Assessing QA Compliance of internal quality system and associated records.

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Contact Information:

Address:  Hobson Prior International Ltd
Wellington Gate
7-9 Church Rd.
Tunbridge Wells
Tel:  01892 612 612
Fax:  01892 612 613
Website:  Visit Our Web Site

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