Quality Engineer (Hybrid - Eagan, MN)

3mcompany; Eagan, Northern (MN, KY); Hybrid; USD 106,000 - 146,000; Full time

Benefits offered by this job

Hybrid eligibility

Travel up to 20%

Relocation assistance

Job summary

Solventum is seeking a Quality Engineer to support marketed medical device and drug products, manage changes, CAPA, and risk management. You will review batch records and collaborate with internal and external teams to ensure compliance and performance.

Ideal candidates have a strong background in quality engineering, data analysis, and cross-functional project leadership, with familiarity in regulatory requirements and QMS systems. Hybrid work with travel to Eagan, MN is available.

Qualifications

• Bachelor’s Degree or higher and 7+ years in quality/engineering/lab.
• Experience in drug/pharmaceutical/medical device industry is a plus.
• Strong data-driven problem solving and cross-functional collaboration.

Responsibilities

• Support marketed medical device and drug products by managing changes, handling CAPA, and risk management.
• Review batch records for drug product release and investigate deviations.
• Collaborate with internal teams and suppliers to ensure performance and compliance.

Skills

Quality engineering

Cross-functional collaboration

Regulatory awareness

Data analysis

Education

Bachelor’s Degree or higher

Tools

Gage R&R

ANOVA

FMEA

SPC

DOE

Job description

At Solventum, we improve lives by helping healthcare professionals do their best work. Join a team using innovation and insight to make a real impact on the future of healthcare. All roles listed are with Solventum, and we’re committed to protecting your personal information—learn more in our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/**Job Description:****Quality Engineer****3M Health Care is now Solventum****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.**Your 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 AND seven (7) years of experience in combined product, quality, engineering, and/or laboratory/technical experience in a private, public, government or military environmentANDIn addition to the above requirements, the following are also required:* Three (3) years of experience in the drug, pharmaceutical, and/or medical device industryAdditional qualifications that could help you succeed even further in this role include:* 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.**Work location:*** **Hybrid Eligible (Job Duties allow for some remote work but require travel to Eagan, MN)****Travel: May include up to 20% domestic/international****Relocation Assistance: May be authorized****Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).****Supporting Your Well-being**Solventum offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.Applicable to US Applicants Only:The expected compensation range for this position is $106,000 - $145,750, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). Additional information is available at: https://www.solventum.com/en-us/home/our-company/careers/#Total-Rewards Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of **@solventum.com**. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.**Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.**