Medical Device Supplier Quality Engineer – Travel

React Health; Bothell (WA); Presencial; USD 85.000 - 110.000; Jornada completa

Descripción de la vacante

React Health is seeking a Supplier Quality Engineer to ensure incoming parts and assemblies meet procedural requirements. You will drive supplier qualification, changes, monitoring, and continuous improvements across domestic and international suppliers.

The role requires 3+ years in medical device supplier quality, knowledge of 21 CFR 820, ISO 13485:2016, ISO14971, and strong communication skills. Travel ~25% is expected in a growth‑oriented environment.

Formación

• Minimum three (3) years of experience in engineering, supplier quality or similar in the medical device industry.
• Bachelor’s degree in engineering or life science discipline.
• Excellent communication and documentation skills.
• Must be able to work effectively with diverse groups of people.
• Strong organization and attention to detail skills.
• Knowledge and experience of 21 CFR 820, ISO 13485:2016, ISO14971.

Responsabilidades

• Supplier approval and monitoring, part qualification, inspection plan generation, pFMEA, control planning, test method and process validation, process improvements, SCAR / CAPA, NC, and change management.
• Supports manufacturing operations by resolving and eliminating supplier caused non-conformances.
• Works cross-functionally to prevent supplier caused part shortages.
• Leads supplier quality system and process audits to ensure supplier’s capabilities meet compliance and quality needs.
• Monitors supplier quality metrics and utilizes them to identify and drive process improvements.
• Attends and participates in departmental meetings and training sessions to maintain professional competence.
• Ensures all department compliance guidelines are met.
• Performs other duties as delegated by the supervisor within the department scope.

Conocimientos

Communication

Documentation

Team collaboration

Regulatory knowledge

Project management

Six Sigma

Lean

Educación

Bachelor's degree in engineering or life sciences

Master’s degree in engineering or life science

Descripción del empleo

React Health is seeking a Supplier Quality Engineer to ensure incoming parts and assemblies meet procedural requirements. You will drive supplier qualification, changes, monitoring, and continuous improvements across domestic and international suppliers.

The role requires 3+ years in medical device supplier quality, knowledge of 21 CFR 820, ISO 13485:2016, ISO14971, and strong communication skills. Travel ~25% is expected in a growth‑oriented environment.