Medical Device QA Engineer – Lifecycle & Risk Lead

Solventum-; San Antonio (TX); Hybrid; USD 124,000 - 171,000; Full time

Benefits offered by this job

Hybrid work

Relocation assistance may be available

Comprehensive benefits

Job summary

Solventum is seeking a Specialist Quality Assurance Engineer in a hybrid role based in the United States with onsite in San Antonio, TX. You will lead quality activities across the product lifecycle, ensuring design verification, validation, and risk management for Solventum Restorative Healing Technologies.

You will mentor engineers, drive risk analyses, and support post-market surveillance while aligning with regulatory requirements and company quality systems.

Qualifications

• Bachelor’s degree in engineering or science with 7+ years in regulated design or quality engineering.
• Experience with medical devices and regulatory standards such as ISO 13485, FDA CFR 820.
• Strong knowledge of risk management per ISO 14971 and usability considerations (IEC 62366).
• Experience leading cross-functional teams and quality activities across lifecycle.

Responsibilities

• Lead quality assurance activities for new product development and sustaining activities.
• Develop risk management plans and conduct risk analyses per ISO 14971.
• Review production release documents and change controls for critical QC.
• Mentor engineers and support audit readiness for internal and regulatory reviews.

Skills

Quality Assurance

Medical Devices

Risk Management

Regulatory Compliance

Education

Bachelor's degree in Engineering or Science

7+ years design or quality engineering experience

Tools

ISO 13485

ISO 14971

IEC 62366

FDA CFR 820

CQE certification

Job description

Solventum is seeking a Specialist Quality Assurance Engineer in a hybrid role based in the United States with onsite in San Antonio, TX. You will lead quality activities across the product lifecycle, ensuring design verification, validation, and risk management for Solventum Restorative Healing Technologies.

You will mentor engineers, drive risk analyses, and support post-market surveillance while aligning with regulatory requirements and company quality systems.