Impactful Supplier Quality Engineer — Medical Devices

React Health Holdings, LLC; Bothell (WA); On-site; USD 85,000 - 125,000; Full time

Job summary

React Health Holdings, LLC is seeking a skilled Supplier Quality Engineer to assure the quality of components and supplier performance across our medical device supply chain. You will classify suppliers, approve changes, monitor performance, and drive corrective actions globally.

You will collaborate with cross-functional teams to prevent non-conformances, maintain compliance with 21 CFR 820, ISO 13485, and ISO 14971, and support continuous improvement while traveling as needed.

Qualifications

• 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.

Responsibilities

• 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. Attends seminars and training sessions necessary to maintain appropriate level of professional competence.
• Ensures all department compliance guidelines are met.
• Attends all meetings, in-services training, or continuing education as delegated by the supervisor.
• Provides customer focused interactions.
• Performs all duties necessary for the department as per department policies and procedures.
• Performs other duties and responsibilities as delegated by the supervisor within the scope of practice and the responsibilities in the department.

Skills

Engineering

Supplier quality

Medical device

Communication

Documentation

21 CFR 820

ISO 13485

ISO14971

Education

Bachelor's degree in engineering or life science

Job description

React Health Holdings, LLC is seeking a skilled Supplier Quality Engineer to assure the quality of components and supplier performance across our medical device supply chain. You will classify suppliers, approve changes, monitor performance, and drive corrective actions globally.

You will collaborate with cross-functional teams to prevent non-conformances, maintain compliance with 21 CFR 820, ISO 13485, and ISO 14971, and support continuous improvement while traveling as needed.