drjobs Supplier Quality Engineer (Onsite)

Supplier Quality Engineer (Onsite)

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1 Vacancy
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Job Location drjobs

Bothell, WA - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

POSITION:Supplier Quality Engineer
FULL-TIME/PART-TIME: Full Time
LOCATION: BOTHELL WA
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
  • 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 non-conformances.
  • Works cross-functionally 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 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.
ABOUT THE ORGANIZATION React Health is a leading U.S. sleep respiratory and cardio-pulmonary 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.

Employment Type

Full Time

Company Industry

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