Quality Engineer (Hybrid - Eagan, MN)

SOLVENTUM•Eagan, MN

2d•$106,000 - $145,750•Hybrid

About The Position

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 As a Quality 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. Here, you will make an impact by: Supporting marketed medical device and drug products by managing changes, handling complaints, conducting CAPA, leading risk management, performing design validation, developing and validating physical and analytical test methods, and ensuring compliance with our QMS and global medical device and drug product regulations. Reviewing batch records for drug product release, investigating, escalating, and resolving nonconformances and deviations. Collaborating with internal cross-functional team members and external suppliers to ensure performance. Preparing for and participating in government inspections, and customer, notified body, and internal audits. Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.

Requirements

Bachelor’s Degree or higher AND seven (7) years of experience in combined product, quality, engineering, and/or laboratory/technical experience in a private, public, government or military environment
Three (3) years of experience in the drug, pharmaceutical, and/or medical device industry
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Nice To Haves

Experience leading and collaborating on cross-functional projects.
Experience applying statistical and quality engineering tools, such as Gage R&R, ANOVA, FMEA, SPC, process capability analysis, regression analysis, and design of experiments (DOE).
Experience working in an engineering, analytical chemistry, or other laboratory-based technical role.
Experience analyzing technical, quality, manufacturing, and/or product-related issues and supporting risk-based decisions.
Experience managing multiple priorities, projects, or initiatives and achieving established objectives.
Experience communicating technical information to stakeholders through verbal discussions, presentations, and written communications.
Experience leading process improvement initiatives.

Responsibilities

Managing changes, handling complaints, conducting CAPA, leading risk management, performing design validation, developing and validating physical and analytical test methods, and ensuring compliance with our QMS and global medical device and drug product regulations.
Reviewing batch records for drug product release, investigating, escalating, and resolving nonconformances and deviations.
Collaborating with internal cross-functional team members and external suppliers to ensure performance.
Preparing for and participating in government inspections, and customer, notified body, and internal audits.
Complying with corporate policies, procedures and security standards while performing assigned duties.