Quality Engineer (Hybrid - Eagan, MN)

SOLVENTUM•Eagan, MN

4d•Hybrid

About The Position

Solventum is a new healthcare 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. 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. You will support marketed 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 drug product regulations. You will also review batch records for drug product release, investigate, escalate, and resolve nonconformances and deviations, and collaborate with internal cross-functional team members and external suppliers to ensure performance. Additionally, you will prepare for and participate in government inspections, agency audits, and internal audits.

Requirements

Bachelor’s Degree or higher (completed and verified prior to start)
Five (5) years of combined product, quality, engineering, and/or laboratory/research & development 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 applying analytical and problem‑solving approaches in technical, quality, or regulated environments, including prioritizing work to meet defined deliverables or timelines
Experience leading or collaborating on cross‑functional projects within product development, quality, engineering, or laboratory environments
Experience applying statistical and quality engineering tools, such as Gage R&R, Analysis of Variance (ANOVA), Failure Modes and Effects Analysis (FMEA), Statistical Process Control (SPC), process capability analysis, regression analysis, and design of experiments (DOE)
Work experience in analytical chemistry or a chemistry‑based role supporting product development, quality, or manufacturing activities

Responsibilities

Supporting marketed 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 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 participate in government inspections, agency audits, and internal audits.
Complying with corporate policies, procedures and security standards while performing assigned duties.