Senior Quality Engineer m/f/x

Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear with us. In the interim, our Privacy Policy here: / solventum. com/en-us/home/legal/website-privacy-statement/applicant-privacy/ continues to apply to any personal information you submit, and the 3M-branded positions listed on our Careers Page are for Solventum positions. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

3M Health Care is now Solventum

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. Because 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. 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

• 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

• Initiating, reviewing, approving and providing guidance on change controls.

• Performing, analysing and interpreting statistical data using a detailed understanding of statistical tools and methods (such as DOE, sampling rationale etc. )

• Giving guidance to Quality Engineering in the development of sampling plans

• Leading investigations and providing technical guidance to peers in relation to CAPAs, NC/NCMRs and SCARs to address compliance issues and providing guidance to suppliers and engineering. Leading the implementation of robust solutions

• Ensuring compliance is maintained for Product Manufacturing, Packaging and Labeling.

• Performing and leading Internal and Supplier Audits.

• Facilitating and participating in external regulatory body audits, e. g. , ISO and FDA

• Implementing Key Performance Indicators within the Quality Assurance area to align with site and global quality objectives.

• Complying with all relevant training required and adhere to relevant associated documentation.

• Abiding to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.

• Following strict adherence to the requirements of CGMP.

• Ensuring compliance to quality systems and all applicable regulations/standards, and internal procedures.

Your Skills and Expertise

To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:

• Degree in Engineering or Science related field

In addition to the above requirements, the following are also required:

• Five (5) years' experience working in a regulated environment, specifically medical device, FDA or ISO 13485 registered work environments is preferrable.

Additional qualifications that could help you succeed even further in this role include:

• Strong computer skills (MS Excel, PowerPoint, Word etc. )

• Strong knowledge of statistical tools and techniques

• Strong knowledge of FMEA's (Failure Mode and Effects Analysis) and root cause analysis tools.

• Strong knowledge of problem solving techniques

• Ability to effectively communicate highly technical information, both verbally and in writing, to both non-technical and technical associates.

• Knowledge of the Quality System Regulation and associated regulations and standards.

Work location: Athlone, Ireland

• Hybrid Eligible (Job Duties allow for some remote work but require travel to Athlone at least 3 days per week)

• Travel: Flexible and available to support business need as required

Relocation Assistance: May be authorized

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 a domain of @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.