Quality Engineer – MedTech, CAPA & Validation (Hybrid)

3mcompany

Eagan, Northern (MN, KY)

Hybrid

USD 106,000 - 146,000

Full time

3 days ago
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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

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.

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