POSITION:Supplier Quality Engineer FULLTIME/PARTTIME: Full Time LOCATION: BOTHELL WA React Health is a fast paced growth oriented manufacturer and distributor of medical equipment serving the respiratory sleep and cardiology patients caregivers physicians and providers. React Health sells and supports its product and services in the acutecare nonacute and home medical equipment markets. React Health has built a model that combines manufacturing and distribution of products and services to meet the challenges of the undiagnosed as well as those needing therapies after diagnosis in the sleep and respiratory population. 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 crossfunctionally to support supplier classification approval changes monitoring and improve incoming part quality and eliminate supplier caused nonconformances. 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
- Bachelors degree in engineering or life science discipline.
- ISO 13485 Lead Auditor certification.
- 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
- Masters 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 nonconformances.
- Works crossfunctionally to prevent supplier caused part shortages.
- Leads supplier quality system and process audits to ensure suppliers capabilities meet compliance and quality needs.
- Monitors supplier quality metrics and utilizes them to identify and drive process improvements.
- Uses project management tools.
- 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 inservices 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 drugfree workplace. We are an EqualOpportunity 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. ABOUT THE ORGANIZATION React Health is a leading U.S. sleep respiratory and cardiopulmonary device manufacturer distributor and diagnostic services provider based in Florida. React Health is focused on delivering comprehensive and integrated solutions to improve outcomes and the lives of patients with highly correlated sleep and respiratory conditions.
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