Supplier Quality Engineer

React Health Holdings, LLC; Bothell (WA); Vor Ort; USD 85.000 - 125.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Engineering

Supplier quality

Medical device

Communication

Documentation

21 CFR 820

ISO 13485

ISO14971

Ausbildung

Bachelor's degree in engineering or life science

Jobbeschreibung

React Health is a fast-paced, growth-driven manufacturer and distributor of medical equipment, dedicated to supporting patients, caregivers, physicians, and healthcare providers. With a focuson respiratory and sleep health sectors, we offer a comprehensive range of products and services across acute care, non-acute care, and home medical equipment. By integrating manufacturing and distribution, React Health addresses the needs of both undiagnosed individuals and those requiring therapy after diagnosis, particularly within the sleep and respiratory care sectors.

GENERAL SUMMARY

Your primary responsibility is to ensure the quality of supplied components (parts and assemblies) ensuring suppliers meet all procedural requirements. In this role, you will work cross-functionally to support supplier classification, approval, changes, monitoring and improve incoming part quality and eliminate supplier caused non-conformances. The ideal candidate will be able to proactively engage with the supplier to prevent issues from occurring and drive improvements throughout the supply chain. Domestic and international travel can be expected.

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.

Preferred Education

• Master's degree in engineering or life science discipline

Preferred Experience

• Project Management
• Six Sigma (DMAIC)
• Lean
• Experience working with and/or auditing domestic and international suppliers.
• Excellent attention to detail and project management skills.
• Excellent written/oral communication skills required. Must be able to work effectively with diverse groups of people

Physical Demands

• Requires normal visual acuity and hearing.
• Typically, employees sit comfortably to do their work, interspersed by brief periods of standing, walking, bending, carrying papers and books, and extensive periods requiring the use of computer terminals to accomplish work objectives.
• Required to sit and use their hands and fingers to handle or feel and manipulate keys on a keyboard.
• Additional skills may be required to perform additional task(s) specific to work location, department or line of business.

Working Conditions

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

DUTIES AND ESSENTIAL FUNCTIONS

Each Employee consistently demonstrates the following essential functions:

• 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.

Reasonable accommodations may be made to accommodate individuals with disabilities to perform the basic functions of the position without compromising client care. React Health is an Equal Opportunity/Affirmative Action Employer and is committed to providing a drug-free workplace. We are an Equal-Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class.