As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, Solventum pioneers 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.
We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.
The Impact You'll Make in this Role
* Representing Quality function in Site Management meetings as required.
* Acting as a delegate for the Quality Lead.
* Acting 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 assessing and providing 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
To set you up for success in this role from day one, Solventum requires (at a minimum) the following 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 preferable
Additional qualifications that could help you succeed even further in this role include:
* 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