Senior, Manufacturing Quality Engineer

React Health Holdings, LLC•Bothell, WA

13h•$135,000 - $145,000•Onsite

About The Position

The Senior Manufacturing Quality Engineer leads process risk management for manufacturing transfer and daily production demand and identifies and supports continuous improvement opportunities. The role is based onsite in a predominantly office and manufacturing environment in Bothell, Washington. React Health is a growth-driven manufacturer and distributor of medical equipment serving patients, caregivers, physicians, and healthcare providers. Its products and services span acute care, non-acute care, and home medical equipment, with a focus on respiratory and sleep health.

Requirements

At least 7 years of experience, or equivalent experience, in medical device manufacturing.
Experience applying ISO 14971, 21 CFR 820, ISO 13485, IEC 62304, and IEC 60601.
Bachelor’s degree in an engineering or life science discipline.
Experience with manufacturing transfer, process validation, and sustaining mechanical and software-driven devices.
Experience creating and maintaining process risk management.
Experience developing test methods and validating those methods.
Experience developing and implementing inspection plans.
Strong technical ability using computational tools and electronic QMS.
Ability to quickly learn new applications, tools, and concepts.
Strong work ethic and ability to excel in a flexible, fast-paced work environment.
Ability to provide guidance and mentorship in quality principles and practices.
Normal visual acuity and hearing.
Ability to sit and use hands and fingers to handle or feel objects and manipulate a keyboard; work may also involve brief periods of standing, walking, bending, and carrying papers and books, as well as extensive computer-terminal use.

Nice To Haves

Master’s degree in an engineering or life science discipline.
Excellent written and oral communication skills.
Ability to work effectively with diverse groups of people.
Six Sigma (DMAIC).
Lean.

Responsibilities

Lead process risk management for manufacturing transfers and daily production demand.
Identify and support continuous improvement opportunities.
Perform metrology, process mapping, pFMEA, control planning, test method validation, validation, process improvements, CAPA, nonconformance, and change management activities.
Review and approve changes to currently commercialized products with respect to product process risk management.
Apply statistics to inform business decisions.
Conduct failure investigations and root cause analyses.
Use critical thinking to support business continuity and improve systems in lower-maturity processes.
Coordinate and work closely with engineering, logistics, finance, and program management disciplines to define system specifications and requirements.
Attend and participate in departmental meetings, seminars, training sessions, in-service training, and continuing education as delegated or needed to maintain professional competence.
Ensure department compliance guidelines are met.
Provide customer-focused interactions.
Perform duties required by department policies and procedures, as well as other duties delegated by the supervisor within the scope of the role.