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Niamh Hlubek
Life Science

+353 87 114 6347
[email protected]
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Details

Global Manager Innovation Quality


Reference:NHL/APIT-407305 Location: Galway
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Manager

Global Manager Innovation Quality

NHL/APIT-407305

Job Purpose:

This is a key role within the Global Quality team but also within the broader integrated Innovation engine. The Innovation Quality team is central to the integrated innovation process and the team partners very closely with all the functions in the product life cycle from R&D and GE teams through to Operations and supports our Commercial and Marketing teams.

Key Responsibilities:

Innovation Quality

  • Partner with R&D, Global Engineering(GE) and Operations to support the development and execution of new products and processes as outlined on the Innovation roadmaps
  • Support / provide resources to ensure appropriate quality validations are complete on all new products / processes, including but not limited to:
  • Carry out risk assessments with the appropriate technical experts at all stages of the development cycle
  • Develop validation plans (appropriate to the stage of the development cycle), ensure execution of these validation plans and review all results
  • Follow up on issues highlighted during downstream/customer validation testing to ensure the technical teams carry out root cause analysis and develop an understanding of the product / process performances.
  • Ensure all product claims are fully validated and appropriate control plans are put in place to ensure they are met on an ongoing basis once transferred to production. This focus on claim definition, validation and control requires collaboration with Legal, Marketing, R&D, GE and Operations.
  • Ensure compliance to Stage Gate methodologies including all hand-off documents are completed as required for each Gate crossing
  • Monitor feedback in the first 6-12 months post-market launch(for new products)and ensure that issues from the various customer channels are documented and resolved expeditiously
  • Review/update/document our Innovation quality processes that underpin an effective QMS in line with ISO 13485 requirements
  • Support the R&D and GE teams in early stage idea screening.
Key Requirements:
  • Bachelor’s Degree in an engineering or a science / mathematical discipline is essential
  • An MBA or Master’s Degree in a technical field would be an advantage
  • 10+ years’ industry experience in new product/process development and quality validations
  • Experience of new product launches, early/late stage validation & industrialization stages, operations & quality processes and Supply Chain practices
  • Strong analytical skills
  • Proficient in Microsoft Office applications (e.g., Word, PowerPoint, Excel, and Access)
Desirable:
  • Black belt in Six Sigma
  • Experience in statistical analysis software (e.g. JMP)
  • Understand the application of ISO 13485 from a product design & development perspective .
Additional Information:
  • International travel required, approx. 15%
Reach out to Niamhat [email protected] or0871146347 for more information.