Our client, a medical device company in Galway are currently looking to recruit a Software Quality Engineer for their site.
Lead Quality, Compliance and Computer Software Validation (CSV) activities in relation to software used in business systems, laboratory & manufacturing equipment, product development of products.
- 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.
- 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.
- 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
- 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 / firstname.lastname@example.org
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