POSITION: Senior, Manufacturing 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 focus on 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
This role, the Senior Manufacturing Quality Engineer leads process risk management for manufacturing transfer and daily production demand and identifies and supports continuous improvement opportunities.
QUALIFICATIONS
- 7+ years of experience or equivalent experience in Medical Device manufacturing and the application of ISO14971, 21CFR820, ISO13485, IEC62304, IEC60601.
- Bachelor’s degree in engineering or life science discipline
- Experience with manufacturing transfer, process validation and sustaining of mechanical and software driven devices.
- Experience with process risk management creation and maintenance.
- Experience with test method development and the validation of those test methods.
- Experience with the development and implementation of inspection plans.
- Strong technical ability using computational tools and electronic QMS.
- Ability to quickly learn new applications, tools, and concepts.
- Strong work ethic and an ability to excel in a flexible and fast-paced work environment.
- Ability to provide guidance and mentorship of good quality principles and practices.
Preferred Education
- Master’s degree in engineering or life science discipline
- Preferred Experience
- Excellent written/oral communication skills required.
- Must be able to work effectively with diverse groups of people
- 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
- Onsite (not hybrid or remote)
DUTIES AND ESSENTIAL FUNCTIONS
Each Employee consistently demonstrates the following essential functions: - Metrology, process mapping, pFMEA, control planning, test method validation, validation, process improvements, CAPA, NC, and change management.
- Ability to review and approve changes to currently commercialized product w.r.t. the process risk management of the product.
- Applies statistics to make business decisions.
- Ability to conduct failure investigation and root cause analysis.
- Must be able to work in lower maturity processes using critical thought to provide pathways for business continuity and improve the systems.
- Coordinate and work closely with other engineering, logistics, financial, and program management disciplines to define system specifications and requirements.
- 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.
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