Senior, Manufacturing Quality Engineer

React Health Holdings, LLC; Bothell (WA); On-site; USD 110,000 - 150,000; Full time

Job summary

React Health in Bothell, WA is seeking a Senior Manufacturing Quality Engineer to lead process risk management for manufacturing transfers and daily production. You will identify improvements and ensure compliance with ISO14971, 21 CFR 820, ISO13485, and IEC standards while collaborating with cross-functional teams.

The role emphasizes hands-on quality engineering in a fast-paced medical device environment, with responsibilities spanning metrology, validation, CAPA, and change control, and

Qualifications

• 7+ years of experience in Medical Device manufacturing and ISO standards.
• Bachelor’s degree in engineering or life science.
• Experience with manufacturing transfer, process validation and sustaining of devices (mechanical and software driven).
• Experience with process risk management creation and maintenance.
• Experience with test method development and validation.
• Experience with inspection plans development.
• Strong technical ability using computational tools and electronic QMS.
• Ability to quickly learn new applications, tools, and concepts.
• Strong work ethic in a fast-paced environment.
• Ability to mentor others in quality principles.

Responsibilities

• Metrology, process mapping, pFMEA, control planning, test method validation, validation, process improvements, CAPA, NC, and change management.
• Review and approve changes to products with respect to process risk management.
• Apply statistics to make business decisions.
• Conduct failure investigation and root cause analysis.
• Support lower maturity processes with critical thinking for business continuity.
• Coordinate with engineering, logistics, finance, and program management to define system specs.
• Attend and participate in departmental meetings and trainings.
• Ensure compliance with department guidelines and policies.
• Provide customer-focused interactions.

Skills

ISO standards

Mfg transfer

Process validation

Risk management

Test method validation

Inspection plans

QMS tools

Statistics

Mentorship

Education

Bachelor’s degree in engineering or life science

Master’s degree in engineering or life science

Tools

DMAIC

Lean

Job description

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 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

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.