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Job Description
As a Senior Quality Systems Engineer, you will play a key role in ensuring the quality and integrity of our medical devices, collaborating with a diverse team of innovators to drive game-changing solutions.
At Solventum, we pioneer breakthrough innovations at the intersection of health, material, and data science, changing patients' lives for the better while enabling healthcare professionals to perform at their best.
Job Responsibilities
- Represent the Quality function in Site Management meetings as required.
- Act as a delegate for the Quality Lead.
- Lead and implement significant process improvements, projects, and cost-saving initiatives using data and quality tools to drive quality decisions.
- Initiate project plans, identify resource allocations, perform, and guide technical activities such as risk documentation, procedural updates, test methods, process/software validation that have major importance to the business.
- Lead investigations and provide technical guidance to peers in relation to Software Validation, CAPAs, and NC, and to address compliance issues and provide guidance to engineering.
- Perform and lead Internal and Supplier Audits.
- Facilitate and participate 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 environment, specifically medical device, FDA, or ISO 13485 registered work environments.
- Lead Auditor or Internal Auditor certification is 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 Arrangements
- Hybrid Eligible (Job Duties allow for some remote work but required to work onsite 2-3 days per week).
- Work Location: Athlone, Co. Westmeath.
- Travel: May include up to 5% domestic/international.
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.