Supplier Quality Engineer

Full-time position based in Bothell, WA. Domestic and international travel up to 25%.

About the role

React Health is a fast-paced, growth-driven manufacturer and distributor of medical equipment focused on respiratory and sleep health sectors. The Supplier Quality Engineer ensures the quality of supplied components and assemblies, working cross-functionally to support supplier classification, approval, changes, monitoring, and improvement of incoming part quality while eliminating supplier-caused non-conformances. The role involves proactively engaging with suppliers to prevent issues and drive improvements throughout the supply chain.

Qualifications

• Minimum three (3) years of experience in engineering, supplier quality, or similar role in the medical device industry
• Bachelor’s degree in engineering or life science discipline
• Excellent communication and documentation skills
• Ability 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, ISO 14971

Preferred qualifications

• Master’s degree in engineering or life science discipline
• ISO 13485 Lead Auditor certification
• Project Management experience
• Six Sigma (DMAIC) and Lean methodologies
• Experience working with and/or auditing domestic and international suppliers

Physical demands

Requires normal visual acuity and hearing. Typically involves sitting comfortably with brief periods of standing, walking, bending, carrying papers and books, and extensive use of computer terminals. Must be able to sit and use hands/fingers to handle or feel and manipulate keyboard keys.

Working conditions

Predominantly operates in an office and manufacturing environment. Travel up to 25%.

Responsibilities

• Supplier approval and monitoring, part qualification, inspection plan generation, pFMEA, control planning, test method and process validation, process improvements, SCAR/CAPA, non-conformance management, and change management
• Support manufacturing operations by resolving and eliminating supplier-caused non-conformances
• Work cross-functionally to prevent supplier-caused part shortages
• Lead supplier quality system and process audits to ensure supplier capabilities meet compliance and quality needs
• Monitor supplier quality metrics and utilize them to identify and drive process improvements
• Use project management tools
• Attend and participate in departmental meetings, seminars, and training sessions to maintain professional competence
• Ensure all department compliance guidelines are met
• Provide customer-focused interactions
• Perform all duties per department policies and procedures
• Perform other duties as delegated by the supervisor within scope of practice