Senior Manager, Quality Engineering

POSITION: Senior Manager, Quality Engineering

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

Senior Manager Quality Engineering is responsible for providing Quality Engineering support to New Product Development, Design Transfer, Manufacturing and Sustaining of commercialized products including Receiving Inspection.


QUALIFICATIONS

• 7 years of experience or equivalent experience in Medical Device Design Control and the application of ISO 14971, 21CFR820, ISO 13485, IEC 62304, IEC 62366, IEC 60601
• 5 years or equivalent experience as a people manager.
• Experience with new design and development, design transfer, manufacturing and sustaining 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 developing and managing Control Plans
• Experience with Inspection Specification creation and Receiving Inspection execution
• Bachelor’s degree in Engineering, or Manufacturing

Preferred Education

• Master's Degree in Engineering, Manufacturing, or Business Administration

Preferred Experience

• Knowledge of QA document processes and systems, Design of Experiments (DOE), process capability studies, failure mode and effects analysis, and statistical tools including statistical process control.
• Knowledge of domestic and international regulatory requirements (i.e. FDA, GxPs, and ISO/EN standards).
• Excellent communications and interpersonal relationship skills including negotiating and relationship management with the ability to drive achievement of objectives.
• Excellent communication skills and the ability to work well with people at all levels are essential.
• Able to demonstrate strong organizational and managerial skills. 
• Capability of working independently, taking ownership for the management of processes, projects and timelines.
• Excellent attention to detail and project management skills.
• Excellent written/oral communication skills. Must be able to work effectively with diverse groups of people.

Physical Demands

Working Conditions

 

• Manage Design Quality, Manufacturing Quality and Quality Control (Receiving Inspection) resources and processes.
• Ability to review and approve changes to commercialized product w.r.t. internal and external process risk management.
• Manages Supplier Quality Engineering, Quality Control Receiving Inspection and Manufacturing Quality Engineering processes and resources.
• Applies statistics to make business decisions.
• 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 adjacent functions; production, engineering, supply chain, finance, product management, etc...
• 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.