**Job Title:** Snr Quality Systems Engineer
At Solventum, we enable better, smarter, safer healthcare to improve lives.
We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy.
* 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.
**Responsibilities:
* 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.
* Performing and leading Internal and Supplier Audits.
* Facilitating and participating in external regulatory body audits, e.g. ISO and FDA
**Requirements:
* 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.
**Nice to Have:
* 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.
**Work Details:
* Hybrid Eligible (Job Duties allow for some remote work but required to work onsite 2-3 days per week, in Athlone)
* Travel: May include up to 5% domestic/international]
**Benefits:
* Solventum offers many programs to help you live your best life – both physically and financially.
* Diversity & Inclusion.
**Disclaimer:
* Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.
* Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.