Overview
Senior Quality Systems Engineer Jobs in Athlone, Ireland at HERO Recruitment
Title: Senior Quality Systems Engineer
Company: HERO Recruitment
Location: Athlone, Ireland
Responsibilities
Representing Quality function in Site Management meetings as required.
Acting as a delegate for the Quality Lead.
Act as Quality Systems Software Validation Lead for site.
Leading and implementing significant process improvements, projects and cost saving initiatives using data & quality tools to drive quality decisions.
Initiating project plans, identifying resource allocations, performing and guiding technical activities such as risk documentation, procedural updates, test methods, process / software validation that have major importance to the business.
Leading investigations and providing technical guidance to peers in relation to Software Validation, CAPAs and NC and to address compliance issues and providing guidance to engineering.
Leading the implementation of robust solutions.
Independently assess and provide guidance to Quality and Engineering disciplines.
Performing and leading Internal and Supplier Audits.
Facilitating and participating in external regulatory body audits, e.g. ISO and FDA
Qualifications
Bachelor’s Degree or higher in Engineering or Science related field (minimum level 8)
Five (5) years’ experience working in a regulated environments, specifically medical device, FDA or ISO 13485 registered work environments is preferrable.
Preferred Skills
Lead Auditor or Internal Auditor certification an advantage
Experience with the use of JIRA, Qtest and VERA for documenting software lifecycle is advantageous but not essential.
Knowledge and experience of Oracle, FactoryTalk applications, PEMAC and Bartender is advantageous
Work Type: Hybrid Eligible (Job Duties allow for some remote work but required to work onsite 2-3 days per week, in Athlone)
