Quality Engineer (Hybrid - Eagan, MN OR Remote - United States)
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. 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.
Requirements
- Bachelor’s Degree or higher (completed and verified prior to start)
- Three (3) years of combined product, quality, engineering, and/or laboratory/research & development experience in a private, public, government or military environment
- Two (2) 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.
Benefits
- Medical, Dental & Vision
- Health Savings Accounts
- Health Care & Dependent Care Flexible Spending Accounts
- Disability Benefits
- Life Insurance
- Voluntary Benefits
- Paid Absences
- Retirement Benefits
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
