Engineering Recruiter - +353 86 440 3725 | choices@hero.ie
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 regulated environments, specifically medical device, FDA or ISO 13485 registered work environments is preferable.
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).
Seniority Level: Mid-Senior level
Employment Type: Full-time
Job Function: Medical Equipment Manufacturing
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