Quality Engineer - Healthcare Devices & Drugs

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

Benefits offered by this job

Hybrid work arrangement

Relocation assistance

Job summary

Solventum, a leader in healthcare solutions, seeks a Quality Engineer to join a team improving patient outcomes. You will oversee CAPA, risk management, design validation, and method development to ensure compliance with QMS and medical regulations.

The role requires seven years in quality/engineering with pharma/medical device experience, plus collaboration with suppliers and internal teams. Hybrid work and potential relocation support are provided.

Qualifications

• Bachelor's degree or higher with seven years of combined product, quality, engineering, and/or lab/technical experience in various environments
• Three years of experience in the drug, pharmaceutical, and/or medical device industry

Responsibilities

• Support marketed medical device and drug products by managing changes, handling complaints, performing CAPA, leading risk management, performing design validation, developing and validating test methods, and ensuring QMS compliance.
• Review batch records for drug product release and investigate nonconformances and deviations.
• Collaborate with cross-functional teams and external suppliers to ensure performance.
• Prepare for and participate in government inspections, customer, notified body, and internal audits.

Skills

Quality engineering

CAPA

Regulatory compliance

Risk management

Statistical analysis

Education

Bachelor's degree or higher

Job description

Solventum, a leader in healthcare solutions, seeks a Quality Engineer to join a team improving patient outcomes. You will oversee CAPA, risk management, design validation, and method development to ensure compliance with QMS and medical regulations.

The role requires seven years in quality/engineering with pharma/medical device experience, plus collaboration with suppliers and internal teams. Hybrid work and potential relocation support are provided.