Job Detail

Location Galway
Salary Negotiable
Posted
Role Type Permanent
Contact Dee Curley
email dee@hero.ie

Software Quality Engineer

Software Quality Engineer

Our client, a medical device company in Galway are currently looking to recruit a Software Quality Engineer for their site.

Job Summary:
Lead Quality, Compliance and Computer Software Validation (CSV) activities in relation to software used in business systems, laboratory & manufacturing equipment, product development of products.

Responsibilities:

  • Duties specific to Software Quality Assurance;
  • Lead Quality and Compliance activities in relation to Software projects.
  • Support, guide, and monitor projects, to ensure that approved software development standards, processes, and procedures are adhered to, while also guiding the adoption of industry best-practices.
  • Ensure that processes, SOPs and forms for computer systems control and validation continue to meet the requirements of relevant regulations and are fit for purpose.
  • Collaborate with project teams to determine the validation strategy and plan for execution.
  • Quality reviewer on CSV and system supporting documentation.
  • Author computer system validation documentation; test scripts, protocols, reports.
  • Pre and post execution approval for all validation test scripts.
  • Review and approval of deviations arising from computer system validation activities. Provide input into addressing deviations and approval of deviation outcome.

Education/Experience:

  • B.Sc. degree in Computer Science or Quality Assurance, or equivalent industrial experience with Computer Software Validation within the medical device industry, of which at least two years must be within a quality assurance or related role.
  • Experience of implementation and validation software business systems is desired.
  • Understanding of ISO 13485 and FDA QSR quality standards, particularly 21 CFR Partsll & 820.
  • Familiarity with GAMP5 Guideline for 'Risk Based approach to GxP Compliant Computerised systems.

Specific Requirements:

  • Ability to work within a team environment to achieve agreed company goals.
  • Ability to communicate effectively with all levels of the company.
  • Ability to meet deadlines and follow through on assigned deliverables.
  • Attention to detail.
  • Proficiency in use of desktop software applications such as MS Office

Environmental Conditions:

  • Typical office environments, with work also performed in R&D labs and manufacturing environment, and at customer/supplier locations.

For further information on this Software Quality role in Galway please contact Dee Curley on 086 7902191 / dee@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/
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Software Quality Engineer

Dee Curley

Role Type Permanent
Contact Dee Curley
email dee@hero.ie
mobile +353 86 790 21 91
linkedIn profile click here