Senior Manager, Quality Engineering

Bothell, WA - USA

Monthly Salary: Not Disclosed

Posted on: 11 hours ago

Vacancies: 1 Vacancy

Job Summary

POSITION: Senior Manager Quality Engineering

FULL-TIME/PART-TIME: Full Time

LOCATION:

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

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

QUALIFICATIONS

7 years of experience or equivalent experience in Medical Device Design control and the application of ISOCFR820 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
Bachelors in Engineering

Preferred Education
Masters in Engineering

Preferred Experience

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

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 environment and research and development laboratory as required

DUTIES AND ESSENTIAL FUNCTIONS

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. 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.

Required Experience:

Senior Manager

POSITION: Senior Manager Quality EngineeringFULL-TIME/PART-TIME: Full TimeLOCATION: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...

7 years of experience or equivalent experience in Medical Device Design control and the application of ISOCFR820 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
Bachelors in Engineering