QA Engineer, Specialist

About The Company Solventum is a pioneering healthcare technology company dedicated to improving lives by enabling healthcare professionals to perform at their best. Building upon a long legacy of innovation, Solventum specializes in creating breakthrough solutions at the intersection of health, material, and data science. The company is committed to delivering smarter, safer, and more effective healthcare products that positively impact patient outcomes and enhance clinical workflows. With a focus on cutting-edge research and development, Solventum partners closely with the brightest minds in the healthcare industry to develop solutions that meld advanced technology with compassion and empathy. The organization values integrity, professionalism, and continuous improvement, fostering an environment where innovation thrives and employee growth is prioritized. About The Role The Specialist Quality Assurance Engineer role at Solventum offers an exciting opportunity to contribute to the development and lifecycle management of medical devices within the company’s Restorative Healing Technologies (RHT) portfolio. As a key member of the quality team, you will serve as a subject matter expert in quality and design assurance, supporting both new product development and sustaining activities to ensure the highest standards of quality and reliability. Your responsibilities will include overseeing design inputs, verification and validation processes, risk management, and post-market surveillance activities. You will collaborate with cross-functional teams such as manufacturing, supplier quality, regulatory affairs, and product development to ensure compliance with industry standards and regulations. This role provides a platform to influence product quality from conception through end-of-life, ensuring patient safety and regulatory adherence while fostering continuous improvement initiatives. Qualifications Bachelor’s degree or higher in an engineering or science discipline (completed and verified prior to start)Minimum of seven (7) years of design or quality engineering experience in a regulated industry (medical devices, pharmaceuticals, etc.)Master’s degree in Biomedical Engineering, Mechanical Engineering, Chemistry, Materials Science, or related field (preferred)Proven experience with medical device regulations and standards such as ISO 13485, FDA CFR 820, ISO 14971, IEC 62366, and ISO 10993Knowledge of risk management, design verification and validation, and lifecycle management practicesProfessional certification such as ASQ Certified Quality Engineer (CQE) or equivalent (preferred)Six Sigma experience or certification (preferred)Strong analytical, problem-solving, and communication skillsAbility to work collaboratively in cross-functional teams and mentor junior staffLegally authorized to work in the country of employment without sponsorship Responsibilities Serve as the Quality/Design Assurance lead for product lifecycle management and quality systems related to Solventum’s RHT productsProvide expertise in development, execution, and reporting of activities including test method validation, design verification, validation, and risk managementLead cross-functional quality activities such as design verification, usability/human factors, software quality, and supplier quality initiativesDevelop and oversee risk management plans in accordance with ISO 14971, including risk analysis and mitigation strategiesReview and approve production release documentation, ensuring specifications, drawings, and change controls meet quality standardsCollaborate with manufacturing and supplier quality teams to ensure readiness for new components and assembliesLead post-market surveillance activities by analyzing complaint trends, field data, and CAPA effectiveness to identify opportunities for continuous improvementEnsure findings from post-market activities are integrated into risk management files and quality plansConduct root cause analysis and CAPA investigations, providing technical guidance to teamsSupport integration of acquired product quality systems into Solventum’s QMS and lifecycle management processesMentor and develop lower-level engineers, fostering professional growth and technical expertiseSupport audit readiness and serve as a technical SME during internal, regulatory, and notified body inspections Benefits Competitive salary range of $124,000 - $170,500, commensurate with experienceComprehensive health insurance including medical, dental, and vision coverageHealth Savings Accounts (HSA) and Flexible Spending Accounts (FSA) for healthcare and dependent careDisability and life insurance benefitsPaid time off, holidays, and wellness programsRetirement plans and savings optionsRelocation assistance (if applicable)Flexible hybrid work arrangements, allowing some remote workOpportunities for professional development and continuous learning Equal Opportunity Solventum is an equal opportunity employer. We are committed to fostering an inclusive environment where all qualified applicants receive consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status. We value diversity and are dedicated to providing a workplace that respects and promotes individual differences. All employment decisions are made based on qualifications, merit, and business needs.