Senior Medical Device QA Engineer – Risk & Lifecycle

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

Benefits offered by this job

Hybrid work model

Job summary

Solventum is seeking a Specialist Quality Assurance Engineer to ensure quality and reliability of Solventum Restorative Healing Technologies products. You will lead QA activities across product lifecycle, including verification, validation, risk management, and post-market surveillance, collaborating with cross-functional teams.

The role requires significant experience in regulated medical devices, with onsite and hybrid work options in San Antonio, TX.

Qualifications

• Bachelor’s degree or higher in engineering or science completed before start.
• Seven years design or quality engineering experience in regulated industry.
• Experience with medical devices and design controls.

Responsibilities

• Serve as Quality/Design Assurance lead for lifecycle management of RHT products.
• Provide QA engineering expertise for test method validation, risk management, and verification/validation.
• Lead cross-functional quality activities across Design Verification, Stability, PMS, CAPA, and supplier quality.
• Lead risk management per ISO 14971 with risk plans, analyses and final reports.
• Develop quality plans using historical data to define measurable quality objectives.
• Review and approve production release docs ensuring critical quality characteristics are defined.

Skills

7+ years QA exp

Education

Bachelor’s degree or higher in engineering or science

Master’s degree in Biomedical Engineering or related

Job description

Solventum is seeking a Specialist Quality Assurance Engineer to ensure quality and reliability of Solventum Restorative Healing Technologies products. You will lead QA activities across product lifecycle, including verification, validation, risk management, and post-market surveillance, collaborating with cross-functional teams.

The role requires significant experience in regulated medical devices, with onsite and hybrid work options in San Antonio, TX.