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Solventum Material Reinvent Quality Manager (Solventum)-R01114922 in Maplewood, Minnesota

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: https://www.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.Job Description:Material Reinvent Quality Manager (Solventum)3M Health Care is now SolventumAt 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 RoleAs a Material Reinvent 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. Here, you will make an impact by:Leading a diverse quality team who support a major, multi-year initiative to redesign, source, and/or replace materials that impact form, fit and/or function of Solventum medical/combination devices and drug products.Collaborating with cross-functional leaders to define and align on strategy, priorities, and right-sized change management based on risk towards the pursuit of united goals.Providing expert level guidance and oversight on Design Controls to drive robust quality planning for the material redesign or replacement projects by ensuring critical to quality attributes are defined and achieved throughout the projects while maintaining compliance to our quality management system and critically assessing and managing risk.Influencing behavior such that teams view change through the lens of patient safety by assessing its impact on the products' risk profile.Leveraging strong leadership, decision-making, problem-solving, continuous improvement, and management skills to create momentum and deliver results in a timely manner by prioritizing personal workloads, as well as providing guidance, direction, and oversight to others.Your Skills and ExpertiseTo 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 an engineering, science, or quality discipline from an accredited institution (completed and verified prior to start) AND seven (7) years of combined experience in Medical Device, Pharmaceutical, or Combination Product experience with a Product Quality or Engineering focus in a private, public, government or military environmentORHigh school diploma/GED from an accredited institution (completed and verified prior to start) AND eleven (11) years of combined experience in Medical Device, Pharmaceutical, or Combination Product experience with a Product Quality or Engineering focus in a private, public, government or military environmentANDIn addition to the above requirements, the following are also required:At least three (3) years of supervisory / m nagement experience.Additional qualifications that could help you succeed even further in this role include:Demonstrated leadership in the application of design controls for new product development or major product redesign that may include Six Sigma experience and/or certification related to the design and manufacture of new Medical Device, Pharmaceutical, or Combination ProductsMaster's degree in Quality Assurance / Management, Chemistry, Biology / Microbiology, Material Science, or related discipline from an accredited institutionScientific knowledge and experience in development of medical devices and relevant regulations and standards applicable to medical device compliance, such as ISO 13485 and ISO 14971ASQ Certified Quality Engineer, ASQ Certified Manager of Quality/Organizational Excellence, or Certified Six Sigma Black BeltSkills including, but not limited to, Quality Engineering, Design Controls (including Design Verification), Process Validation, Risk Management, Test Method Validation, Critical to Quality (CTQ) Definition & Control, Critical Thinking, Statistical Data Analysis, Continuous Improvement, and the ability to navigate complexities and create solutions in highly technical and regulated environmentStrong verbal and written communication skills with the ability to provide diligent, concise, and fact-based communication to Executive Management, cross-functional peers, and your direct report teamWork location: Hybrid in St. Paul, MNTravel: May include up to 20% domestic / internationalRelocation Assistance: May be authorizedMust be legally authorized to work in country of employment without sponsorship...Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity

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