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SalaryReact 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 acute-care, non-acute 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 finished goods and service kits manufactured at contract manufacturers. In this role, you will work cross-functionally to support product transfer and manufacturing. 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.
GENERAL SUMMARY
Your primary responsibility is to ensure the quality of supplied finished goods and service kits manufactured at contract manufacturers. In this role, you will work cross-functionally to support product transfer and manufacturing. 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.
(Candidate must be located in the South Texas Valley, able to commute to Reynosa Mexico from Monday-Friday)
QUALIFICATIONS
QUALIFICATIONS
- Minimum seven (7) years of experience in engineering, Supplier Quality or similar in the medical device industry
- Bachelor’s degree in engineering or life science discipline
- ISO 13485 Lead Auditor certification
- Experience working with and/or auditing domestic and international suppliers.
- 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
- Bilingual in Spanish / English; speaking, reading and writing.
Preferred Education
- Master’s degree in engineering or life science discipline
- Preferred Experience
- Project Management
- Six Sigma (DMAIC)
- Lean
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.
DUTIES AND ESSENTIAL FUNCTIONS
Each Employee consistently demonstrates the following essential functions:
- Supplier approval and monitoring, part qualification, inspection plan generation, metrology, process mapping, 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
- Implements design and manufacturing process changes at supplier level
- 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
- Participates in evaluation and selection of new suppliers
- 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.
- Supports in testing of products.
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.
FULL-TIME/PART-TIME: Full Time
POSITION: Senior Supplier Quality Engineer
LOCATION: TEXAS (Remote)
ABOUT THE ORGANIZATION React Health is committed to providing innovative sleep, sanitation and consumer devices. Our goal is to provide the highest quality products that comply with all regulatory requirements and meet or exceed the market expectations and needs of our customers, employees and investors.
SALARY: $125K- $145K annual salary plus potential bonus based on performance/ Signing Bonus
