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Quality Manager, Medical Device (Combination Products)


  • Dublin
  • See description
  • Permanent full-time
  • Updated 07/10/2017
  • Geetanjali Bhuyan
this job is expired
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Quality Manager/ Quality Engineer for Medical Device - quality lead for Design Reviews of combination products and devices in conjunction with Device Development Team, Regulatory Affairs, R&D And Market Research Team.





Overview of the role:

A role has arisen for a medical device manufacturing and quality expert to join an established pharmaceutical group's quality organisation. This individual will be group SME for all quality-related procedures around the medical device components of combination products. These products will include biosimilars, antibiotics etc. and typical devices to be overseen will include syringes, inhalers and other drug delivery technologies. 

Roles and Responsibilities:

  • Quality lead for Design reviews of Combination Products and Devices in conjunction with Device Development Team, Regulatory Affairs, R&D and Market Research Teams.
  • Quality lead for risk benefit analysis for combination products/device programs
  • Manage Quality Combination Products SOPs
  • Ownership and preparation of Design Verification and Design Validation protocols/reports and risk and usability reports in support of Design History Files
  • Support and facilitate post-approval activities such as Device Design changes
  • Relationship management and regular communication with key medical device suppliers to facilitate development projects and supplier compliance with applicable device requirements
  • Clinic trail involvement, such as formula studies, blinding studies and pK studies
  • Drive Human factor studies that support regulatory submissions
  • Responsibility for Quality aspects of device engineering and change control through the lifecycle of the Combination Products/Device project
  • Oversight of device elements of complaints
  • Participate in joint quality & technical assessments (with Global Device Development) of suppliers and device partners
  • Problem solve and trouble shoot as required
  • Quality oversight for device manufacturing for pivotal manufacturing campaigns

Here are the qualifications required for this position:

  • 3RD Level qualification in Science or Engineering
  • Experience in medical device industry.  Respiratory and Injectable drug-delivery devices experience a distinct advantage
  • Familiarity with ISO 13485, Quality Systems for Medical Devices & FDA QSR 21 CFR 820, in particular working knowledge of Design Control requirements
  • Strong background in the application of ISO 14971:2012, Risk Management for Medical Devices, is essential
  • Experience in the application of ISO 62366, Usability Engineering for Medical Devices
  • Willingness to travel if needed

Ref: 3547
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