Senior Manager, Quality Engineering

React Health Holdings•Bothell, WA

16h

About The Position

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 The Senior Manager Quality Engineering provides resource to support New Product Development, Design Transfer, Manufacturing and Sustaining of commercialized product including Receiving Inspection.

Requirements

7+ years of experience or equivalent experience in Medical Device Design control and the application of ISO14971, 21CFR820, ISO13485, IEC62304, IEC 62366, IEC 60601
5+ years or equivalent experience as a people manager.
Experience with new design, design transfer, manufacturing and sustaining of electro-mechanical and software driven devices.
Experience with Test Method Validation, Design Validation, Design Verification and Process Validation
Experience with Risk Management file creation (use, design and process) and maintenance
Experience with Control Plans
Experience with Inspection Specification creation and Receiving Inspection execution
Bachelor's in Engineering
Excellent attention to detail and project management skills.
Excellent written/oral communication skills.
Must be able to work effectively with diverse groups of people.
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.

Nice To Haves

Master's in Engineering

Responsibilities

Ability to review and approve changes to currently commercialized product w.r.t. the use, design and process risk management of the product.
Manages Design Quality, Manufacturing Quality and Quality Control (Receiving Inspection) resources and processes.
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.
Ability to manage remote employees, effectively and efficiently.
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.