Supplier Quality Engineer

React Health Holdings, LLC•Bothell, WA

7d•$85,000 - $100,000•Onsite

About The Position

The Supplier Quality Engineer is responsible for ensuring the quality of supplied components, including parts and assemblies, and ensuring suppliers meet procedural requirements. The role works cross-functionally to support supplier classification, approval, changes, and monitoring; improve incoming part quality; and eliminate supplier-caused non-conformances. The ideal candidate proactively engages suppliers to prevent issues and drive supply-chain improvements. Domestic and international travel is expected, with travel listed at 25%. The position operates predominantly in office and manufacturing environments.

Requirements

At least three years of experience in engineering, supplier quality, or a similar role in the medical device industry.
Bachelor’s degree in an engineering or life science discipline.
Excellent communication and documentation skills.
Ability to work effectively with diverse groups of people.
Strong organizational skills and attention to detail.
Knowledge and experience with 21 CFR 820, ISO 13485:2016, and ISO 14971.

Nice To Haves

Master’s degree in an engineering or life science discipline.
ISO 13485 Lead Auditor certification.
Project management experience.
Six Sigma (DMAIC) experience.
Lean experience.
Experience working with and/or auditing domestic and international suppliers.
Excellent attention to detail and project management skills.
Excellent written and oral communication skills and ability to work effectively with diverse groups of people.

Responsibilities

Support supplier approval and monitoring, part qualification, inspection plan generation, pFMEA, control planning, test method and process validation, process improvements, SCAR/CAPA, nonconformance, 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 assess suppliers’ capabilities and compliance with quality needs.
Monitor supplier quality metrics and use them to identify and drive process improvements.
Use project management tools.
Attend and participate in departmental meetings, seminars, and training sessions needed to maintain professional competence.
Ensure department compliance guidelines are met.
Attend meetings, in-service training, or continuing education as delegated by the supervisor.
Provide customer-focused interactions.
Perform duties required by department policies and procedures, along with other duties delegated by the supervisor within the scope of practice and departmental responsibilities.