Quality Engineer – Med Devices & Compliance (Hybrid)

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

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.