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Software Quality Engineer

Job Title: Software Quality Engineer
Contract Type: Permanent
Location: Cork
Industry:
REF: 89720
Job Published: about 2 months ago

Job Description

Our Client a medical device company in Cork are looking to recruit a Software Quality Engineer for their site.

Software Quality Engineer

Key Responsibilities:
  • Site Subject Matter Expert (SME) person and co-ordinator for computer validation/test activities.
  • Site SME for computer software validation (cave) during internal and external audits.
  • Ensure regulatory compliance with internal and external validation regulations, particularly with corporate cave requirements.
  • To co-ordinate activities relating to the implementation and maintenance of the Quality System in order to comply with Corporate, EC, FDA and Canadian requirements.
  • Drive continuous improvement initiatives within the Quality systems department.
  • Ensure relevant procedures are kept up to date and maintained to the relevant standards and to industry best practice.
  • Provide guidance and assistance with the preparation of validation protocols, test protocols, software design specifications, and associated documentation for all cave applications.
  • Participates on project teams to develop clear specifications, evaluate feasibility of concepts, and provide estimates for System designs.
  • Determines Project schedules for remediation of legacy systems and works with cross functional teams to ensure adherence.
  • Provides guidance, training and direction on cave to staff across various functions. Provide software validation/compliance/part 11 leadership.
  • Take part in vendor audits of critical equipment vendors.

Education & Qualifications:
  • Level 8 qualification in Information Technology/Computer Science or equivalent discipline.
  • Preferable 2.5 years experience in a similar role, preferably in a large multinational company.
  • Demonstrate strong communication and problem solving skills.
  • Customer focused approach.
For further information on this Software Quality Engineer role in Cork please contact Ros Lomasney on 0212066287 / Ros@hero.ie
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