Healthcare Quality Engineer: Risk, CAPA & Compliance

Solventum in; Eagan (MN); Hybrid; USD 106,000 - 146,000; Full time

Benefits offered by this job

Hybrid Eligible

Relocation Assistance

Job summary

Solventum seeks a Quality Engineer to support marketed medical devices and drug products, lead CAPA and risk management activities, and drive design validation and test method development. You will collaborate with internal teams and suppliers to assure product quality and regulatory compliance.

The role requires a strong background in quality engineering within healthcare, with hybrid work arrangements and travel up to 20%.

Qualifications

• Bachelor’s degree or higher with 7+ years in product/quality/engineering or lab environments.
• 3+ years in drug/pharmaceutical and/or medical device industry.

Responsibilities

• Support marketed medical device and drug products by managing changes, handling complaints, CAPA, risk management, design validation, and test method development while ensuring QMS and regulatory compliance.
• Review batch records for drug product release and investigate nonconformances and deviations.
• Collaborate with cross-functional teams and suppliers to ensure performance and quality.

Skills

Leadership

Quality engineering

Gage R&R

ANOVA

FMEA

DOE

Education

Bachelor’s Degree or higher

Tools

Gage R&R

Job description

Solventum seeks a Quality Engineer to support marketed medical devices and drug products, lead CAPA and risk management activities, and drive design validation and test method development. You will collaborate with internal teams and suppliers to assure product quality and regulatory compliance.

The role requires a strong background in quality engineering within healthcare, with hybrid work arrangements and travel up to 20%.