Quality Engineer

Overview
Thank you for your interest in joining Solventum.
Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best.
At Solventum, people are at the heart of every innovation we pursue.
Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers' toughest challenges.
Please note that all listed roles are Solventum positions, and our Privacy Policy applies to any personal information you submit.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Job Description
At Solventum, we enable 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.
People and their wellbeing are at the heart of every scientific advancement we pursue.
We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy.
At Solventum, we never stop solving for you.
The Impact You'll Make in this Role
Responsibilities
As a Quality Manager you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world.
You will initiate and perform defined quality activities leading to new or improved processes or systems.
Here, you will make an impact by:
Key Responsibilities will include (but are not limited to) the following:
Initiating and completing technical activities and cost savings as part of process improvements through the update of risk documentation, procedural updates, test methods, process/software validation, etc., that have a significant impact to the business
Initiating, reviewing, and approving change controls
Performing, analyzing and interpreting statistical data using an understanding of statistical tools and methods
Developing a strategy and implementing appropriate sampling methods
Write up and review of CAPAs, NC/NCMRs and SCARs to address compliance issues and providing guidance to suppliers and engineering
Ensuring compliance is maintained for Product Manufacturing, Packaging and Labeling
Performing Internal and Supplier Audits
Supporting and participating in external regulatory body audits, e.g., ISO and FDA
Creating and analyzing data for Quality Metrics
Complying with all relevant training required and adhering to relevant associated documentation
Abiding by Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation
Following strict adherence to the requirements of CGMP
Actively contributing to the enhancement of compliance initiatives for areas of responsibility
Your Skills And Expertise
To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:
Education: Degree in Engineering or Science related field
In addition to the above requirements, the following are also required:
Experience: Three (3) 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:
Strong computer skills (MS Excel, PowerPoint, Word etc.)
Familiarity with statistical tools such as Pareto charts and trend charts
Familiarity with FMEA's (Failure Mode and Effects Analysis) and root cause analysis tools
Experience with problem solving techniques
Ability to effectively communicate technical information, both verbally and in writing, to both non-technical and technical associates
Work location
Work location:
Athlone, Ireland
Work Type:
Hybrid Eligible (Job duties allow some remote work but require travel to Athlone at least 3 days per week)
Travel:
Flexible and available to support business need as required
The information listed above is not a comprehensive list of all duties/responsibilities performed.
This job description is not an employment agreement or contract.
Management has the exclusive right to alter this job description at any time without notice.
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).
Supporting Your Well-being
Solventum offers many programs to help you live your best life – both physically and financially.
To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.
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.
Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process.
Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.
Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with the domain solventum.com.
Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.
Please note: your application may not be considered if you do not provide your education and work history, either by:
1) uploading a resume, or
2) entering the information into the application fields directly.
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