4 Senior Manufacturing Quality Engineer (Onsite) (Bothell, WA) Jobs in Bothell, WA

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Senior Manufacturing Quality Engineer (Onsite) (Bothell, WA)

React Health Holdings, LLC

Bothell, WA | Full Time

$105k-125k (estimate)

4 Months Ago

Senior Manufacturing Quality Engineer (Onsite) (Bothell, WA)

$105k-125k (estimate)

Full Time 4 Months Ago

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React Health Holdings, LLC is Hiring a Senior Manufacturing Quality Engineer (Onsite) (Bothell, WA) Near Bothell, WA

FULL-TIME/PART-TIME: Full Time
POSITION: Senior, Manufacturing Quality Engineer
LOCATION: (Onsite) (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 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
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.
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: $130K-$140K annually plus potential bonus based on performance/ Signing Bonus