Supplier Quality Senior Engineer (Remote - United States)

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. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ applies to any personal information you submit. 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:Supplier Quality Senior Engineer3M 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 Supplier Quality Senior Engineer, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. This role is critical in maintaining the integrity of the Quality of our supplied materials, continuity of our supply chain and ensuring delivery of better, smarter, safer healthcare products to improve patients’ lives. Here, you will make an impact by:Executes cross-functional collaboration & communication: Work closely with internal stakeholders and support suppliers in meeting quality and regulatory requirements by actively applying skills from the Quality Body-of-Knowledge for supplier controls related to components and materials used in medical devices, drug/device combination products, other regulated products, and purchased finished goods.Supports compliance: Identify improvement opportunities to proactively ensure vendor compliance with all applicable internal, domestic, and international quality regulations, including but not limited to US 21 CFR 210, 211, and 820, ISO 13485, ISO 14971, EU MDR, etc.Leads issue resolution & continuous improvement: Collaborate and partner closely with our suppliers to reduce risk, improve processes, and reduce waste using quality improvement tools of process control & monitoring, DOE, risk analysis, problem solving processes, protocol development, trend analysis and reaction, capability analysis and measurement system analysis.Performs supplier qualifications and assessments: Assess new suppliers for suitability and regularly reassess existing suppliers to ensure ongoing compliance and consistent performance through Supplier Qualifications, Supplier Quality Agreements, Supplier Corrective Action Requests (SCARs), Supplier Change Notice evaluations, Supplier Scorecards, and Internal & External Audit SupportYour 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 (completed and verified prior to start) AND three (3) years of Quality, Continuous Improvement, or Operations/Supply Chain functions in the Medical Device/Pharmaceutical/Aerospace industry in a private, public, government or military environmentAdditional qualifications that could help you succeed even further in this role include:ASQ Certified Supplier Quality Professional (CSQP) or Certified Quality Engineer (CQE) desired.Demonstrated experience with quality management systems or regulatory requirements (ISO 13485, ISO 9001, CRF Part 820, MDSAP)Influential in areas including, but not limited to, compliance excellence, continuous improvement, product-related risk mitigation, and/or manufacturing process capability enhancementStrong analytical, root-cause analysis, and problem-solving skills.Ability to work independently and manage multiple projects simultaneously.Proficiency in Microsoft Office Suite and quality management software.Keen attention to detail, with the ability to identify small issues that could escalate into larger problems if left unaddressed.Work location: Remote – United StatesTravel: May include up