Senior Quality Assurance Engineer, Medical Devices — Hybrid

USA SOLVENTUM US LLC; San Antonio (TX); Hybride; USD 124 000 - 171 000; Plein temps

Résumé du poste

Solventum is seeking a Specialist Quality Assurance Engineer to lead QA for new and on‑market products, ensuring design verification, validation, and robust risk management. You will guide cross‑functional teams, manage CAPAs, and drive sustained product quality across the lifecycle.

The role emphasizes regulatory-compliant quality systems, post‑market surveillance, and mentoring junior engineers, with hybrid work options at San Antonio, TX and Eagan, MN locations.

Qualifications

• Bachelor’s degree in engineering or science and seven years of design or quality engineering in a regulated industry.
• Master’s degree in a related field is preferred.
• Solid knowledge of medical device regulatory standards and risk management.

Responsabilités

• Lead Quality/Design Assurance for product lifecycle and quality systems.
• Perform design verification and validation, risk management, and post‑market surveillance.
• Coordinate cross‑functional quality activities with project teams and SMEs.
• Develop risk management plans and final risk reports per ISO 14971.

Connaissances

Quality engineering

Regulated industry experience

Design controls

Formation

Bachelor's degree in engineering or science

Master's degree in Biomedical/Mechanical/Chemistry/Materials Science

Outils

ISO 13485

FDA CFR 820

ISO 14971

EU Medical Device Directive

IEC 62366

ISO 10993

Description du poste

Solventum is seeking a Specialist Quality Assurance Engineer to lead QA for new and on‑market products, ensuring design verification, validation, and robust risk management. You will guide cross‑functional teams, manage CAPAs, and drive sustained product quality across the lifecycle.

The role emphasizes regulatory-compliant quality systems, post‑market surveillance, and mentoring junior engineers, with hybrid work options at San Antonio, TX and Eagan, MN locations.