Senior Manager, Quality Engineering

Bothell, WA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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 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 Manager Quality Engineering supports Design Transfer Manufacturing and Sustaining of commercialized electro-mechanical and software driven devices.

QUALIFICATIONS

7 years of experience or equivalent experience in Medical Device manufacturing
Application of 21CFR820 ISO13485 ISO14971 and IEC 60601
5 years or equivalent experience as a people manager
Experience with design transfer manufacturing and sustaining electro-mechanical and software driven devices
Experience with external process risk management - supplier controls; supplier risk classification onboarding and maintenance component qualification auditing agreements supplier change requests supplier corrective actions etc...
Experience with Quality Control - Inspection Specification creation metrology and Receiving Inspection execution
Experience with internal process risk management - Test Method Validation Process FMEA Control Plans and Process Validation nonconformance
Experience with CAPA and Root Cause Analysis
Engineering degree or degree with work history showing evidence of 10years of experience with process risk management (internal and external) with respect to Legal Manufacturer responsibilities

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 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.

Required Experience:

Senior Manager

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