Qureos Mentor

React Health

<div><div><b>POSITION: </b>Manager, Quality Systems and Compliance<br>
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<b>FULL-TIME/PART-TIME:</b> Full Time<br>
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<b>LOCATION: </b>Bothell, WA<br>
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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.
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<div></div><div><div><div><div><b>GENERAL SUMMARY</b></div><br>
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<div><div><div>The Manger, Quality Systems &amp; Compliance assures the Quality Management System is established and compliant with applicable regulations and standards. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.</div><br>
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<div></div><div><div><div><b>QUALIFICATIONS</b></div><br>
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<div><div><ul><li>At least 2 years of supervisory experience</li>
<li>A minimum of 5 years of experience in a related position</li>
<li>Strong organization and attention to detail skills</li>
<li>Strong working knowledge of FDA 21 CFR Part 806, 820, 821, ISO13485, MDSAP required</li>
<li>Experience leading and coordinating regulatory inspections and audits</li>
<li>Experience leading cross-functional teams</li>
<li>Exceptional attention to detail and a proactive approach to problem-solving</li>
<li>Strong communication skills, both verbal and written, to effectively convey quality standards and engage with stakeholders</li>
<li>Ability to work collaboratively in a team environment while also being self-motivated</li>
<li>A passion for continuous improvement and a commitment to maintaining high standards of quality</li>
<li>Bachelor&rsquo;s degree in Science, Quality Management, Regulatory Affairs</li><br>
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<div></div><div><div><div><b>Preferred Education</b></div>
<ul><li>Masters&rsquo;s degree in Science, Quality Management, Regulatory Affairs</li>
<li>Certification in CQA preferred</li><br>
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<div><div><div><b>Preferred Experience</b></div>
<ul><li>Excellent attention to detail and project management skills.</li>
<li>Excellent written/oral communication skills required. Must be able to work effectively with diverse groups of people.</li><br>
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<div></div><div><div><div><b>Physical Demands</b></div>
<ul><li>Requires normal visual acuity and hearing.
</li><li>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.</li>
<li>Required to sit and use their hands and fingers to handle or feel and manipulate keys on a keyboard.</li>
<li>Additional skills may be required to perform additional task(s) specific to work location, department or line of business.</li><br>
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<div></div><div><div><div><b>Working Conditions</b></div>
<ul><li>Predominantly operates in an office environment. Some work (less than 5%) requires moving and lifting of heavy networking equipment.</li><br>
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<div></div><div><div><div><b>DUTIES AND ESSENTIAL FUNCTIONS</b><br>
Each Employee consistently demonstrates the following essential functions:</div><br>
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<div></div><div><div><ul><li>Assure proper integration and support of medical device standards and regulations.</li>
<li>Lead and coordinate internal audits, regulatory inspections and certification audits</li>
<li>Lead Corrective and Preventive Action (CAPA) Activities</li>
<li>Responsible for managing document control, change control, quality systems processes, organizational training, management reviews</li>
<li>Provide consultation and training on specific QA expertise to internal and cross-functional groups</li>
<li>Train and mentor cross functional staff on quality standards, procedures, and best practices while providing leadership and direction</li>
<li>Establish, monitor and drive continuous improvement in quality performance metrics.</li>
<li>Identify gaps in existing processes as well as the need for new processes.</li>
<li>Collaborate effectively with all functions and teams and at all levels in the organization</li>
<li>Attends all meetings, in-services training, or continuing education as delegated by the supervisor.</li>
<li>Provides customer focused interactions.</li>
<li>Responsible for compliance with company policies and procedures. Ensures all department compliance guidelines are met.</li>
<li>Attends and participates in departmental meetings. Attends seminars and training sessions necessary to maintain appropriate level of professional competence.</li>
<li>Performs all duties necessary for the department as per department policies and procedures.</li>
<li>Performs other duties and responsibilities as delegated by the supervisor within the scope of practice and the responsibilities in the department.</li>
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</div></div></div><div></div><div>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.</div></div>

Manager, Quality Systems and Compliance

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React Health

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Manager, Quality Systems and Compliance