Quality Engineer (Hybrid - Eagan, MN)

USA SOLVENTUM US LLC; Eagan (MN); Hybrid; USD 106,000 - 146,000; Full time

Job summary

Solventum, a leader in healthcare innovation, seeks a Quality Engineer to support marketed medical device and drug products. The role involves managing changes, handling complaints, CAPA, risk management, and ensuring QMS compliance.

Hybrid work in Eagan, MN with up to 20% travel; requires a Bachelor’s degree and 7+ years of relevant experience in pharma/medical device. You will collaborate cross-functionally and prepare for inspections.

Qualifications

• Bachelor’s degree or higher with 7+ years in product/quality/engineering.
• 3 years in drug, pharmaceutical, and/or medical device industry
• Experience leading cross-functional projects.

Responsibilities

• Support marketed medical device and drug products with CAPA and changes.
• Review batch records for drug product release and investigate nonconformances.
• Prepare for inspections and audits.

Skills

Cross-functional collaboration

Statistical analysis

Design of Experiments (DOE)

Risk management

Complaint handling

Education

Bachelor's degree or higher

Tools

Gage R&R

ANOVA

FMEA

SPC

Process capability analysis

Regression analysis

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

• 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

1. 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 AND
2. Three (3) years of experience in the drug, pharmaceutical, and/or medical device industry

Additional Qualifications

• 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

Eligibility

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.

Compensation and Benefits

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

• Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.

Recruitment Integrity

Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process.

Company Culture

A new healthcare company with a rich history. With more than 70 years of delivering healthcare innovations, we continue to move the industry forward by helping to solve our customers’ biggest challenges. 20,000+ employees worldwide. Solventum relies on the courage and the boundless insights of professionals worldwide to achieve exceptional results for our customers and those who rely on them. Healthcare that leads with heart and humility starts with listening and never finishes, only evolves. As long as healthcare challenges remain unsolved, we will be here, united by empathy and a relentless belief that countless lives are improved through our work. Operations in 38 countries. Driven by our dedication to improved outcomes for all we serve, we break through by making unprecedented connections that impact lives. In more than 300 offices and facilities around the world, we work closely with customers and partners to create positive healthcare outcomes that transcend borders. To realize our shared vision, we harness diverse talents and perspectives from every background to not only address our customers' most urgent priorities but anticipate the needs of the future

Equal Opportunity

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.