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Senior Quality Systems Engineer (Digital Health)

Job Title: Senior Quality Systems Engineer (Digital Health)
Contract Type: Permanent
Location: Galway
REF: 88901
Job Published: 11 months ago

Job Description

Contact: Bimi Felix
Telephone: 091730022

Senior Quality Systems Engineer (Digital Health)
Our client, a medical device company in Galway are currently looking to recruit a Senior Quality Systems Engineer (Digital Health) for their site.

Key Responsibilities:
  • Acting as a quality systems subject matter expert champions digital health/ hospital solutions process development and global continuous improvement activities while ensuring they meet regulatory requirements.
  • Must have experience in CAPA - Corrective Action Preventive Action - owning and executing quality system changes.
  • Must have good understanding of quality system and how each quality system element connects.
  • Responsible for maintenance of Healthcare Solutions Quality Plan.
  • Must have experience in working with vendors - understanding what services they are providing and how the service fits into the BSC quality system.
  • Provide insight and expertise on quality system processes and to both internal BSC customers as well as working with external partners.
  • Must be able to apply project management principles and techniques as they relate to quality system planning, implementation and tracking. Must be able to evaluate and manage risk.
  • Facilitates bi-weekly Digital Health & Healthcare Solutions meetings driving actions to conclusion.
  • Basic understanding of software validation methodologies is beneficial.
  • Basic understanding of product development processes is beneficial.

  • Bachelor Degree in the Engineering or Science field, plus 4-6 years of related experience or an equivalent combination of education and work experience
  • Understanding of quality system requirements as stated within 21 CFR Part 820 and ISO 13485
  • Experience with CAPA, Vendor Controls, and External Audits
  • Flexible and positive attitude
  • Comfortable speaking and presenting to leadership
  • Computer literate, network knowledge required
  • Good communication skills
  • Creative thinking and innovation
  • Strong analytical skills
  • Project management skills

For further information on this Senior Quality Systems Engineer (Digital Health) role in Galway please contact Bimi Felix on 091730022 /
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