Supplier Quality Engineer

React Health Holdings•Bothell, WA

19d

About The Position

The Supplier Quality Engineer ensures the quality of supplied components, including parts and assemblies, and verifies that 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 successful candidate proactively engages suppliers to prevent issues and drive supply-chain improvements. Domestic and international travel can be expected, with travel listed as 25%. The position is based in Bothell, Washington, and 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.
Ability to meet the physical demands described, including extended computer-terminal use, sitting, and handling or manipulating keyboard keys.

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.
Project management skills.

Responsibilities

Approve and monitor suppliers; qualify parts; generate inspection plans; and support pFMEA, control planning, test method and process validation, process improvements, SCAR/CAPA, non-conformance, 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 supplier 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, training sessions, in-service training, and continuing education as delegated or needed to maintain professional competence.
Ensure departmental compliance guidelines are met.
Provide customer-focused interactions.
Perform duties required by department policies and procedures and other duties delegated by the supervisor within the scope of the position.