Snr Quality Systems Engineer Job Description:
About Solventum
Solventum enables better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best.
The Impact You'll Make in this Role
* You will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world.
* 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
Your Skills and Expertise
* 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
* 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, Factory Talk applications, PEMAC and Bartender is advantageous
Work Details
* Hybrid Eligible (Job Duties allow for some remote work but required to work onsite 2-3 days per week, in Athlone)
* Athlone, Co. Westmeath
* May include up to 5% domestic/international travel
Requirements
* Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1 B status).
Salary Information
We offer a competitive salary of €80,000 - €120,000 per annum based on experience.
Benefits
* Supporting Your Well-being: Solventum offers many programs to help you live your best life – both physically and financially.
Diversity & Inclusion
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, gender, sexual orientation, age, civil status, disability, family status, or membership of the travelling community.