Quality Assurance Specialist (Remote)
Quality Assurance Specialist (Remote)
Posted on :
07-05-2025
Employer Active
1 Vacancy
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Job Description
POSITION: Quality Assurance Specialist
FULLTIME/PARTTIME: Full Time
LOCATION:(Remote)
React Health is a fast paced growth oriented manufacturer and distributor of medical equipment serving the respiratory sleep and cardiology patients caregivers physicians and providers. React Health sells and supports its product and services in the acutecare nonacute and home medical equipment markets. React Health has built a model that combines manufacturing and distribution of products and services to meet the challenges of the undiagnosed as well as those needing therapies after diagnosis in the sleep and respiratory population.
GENERAL SUMMARY
The Quality Assurance Specialist is a vital member of the Quality team. This role reports to the Manager of Quality Systems and Compliance. The focus of this role is performing document control training assignment/coordination distribution of documents CAPA coordination analyze quality data and other applicable duties.
QUALIFICATIONS
The Quality Assurance Specialist is a vital member of the Quality team. This role reports to the Manager of Quality Systems and Compliance. The focus of this role is performing document control training assignment/coordination distribution of documents CAPA coordination analyze quality data and other applicable duties.
QUALIFICATIONS
- A minimum of a bachelors degree in engineering life sciences 2 years of experience in a related position required;
- Experience and understanding of the overall business environment and required regulations including FDA 21 CFR 820 and ISO 13485:2016
- Ability to build relationships throughout the business and work with cross functional teams
- Demonstrated ability to manage multiple competing priorities and facilitate projects
Preferred Education
- Bachelors degree in engineering life sciences or related field
- Preferred Experience
- Medical device industry desired
- Excellent attention to detail and project management skills.
- Excellent written/oral communication skills required. 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. Some work (less than 5%) requires moving and lifting of heavy networking equipment.
DUTIES AND ESSENTIAL FUNCTIONS
Each Employee consistently demonstrates the following essential functions:
- Perform change orders and assigned associated training in accordance with procedures
- Ensures QMS documents are processed in a timely manner according to procedure
- Ensures proper storage and distribution of controlled documents
- Review and revise SOPs to address changes and improvements and work with employees to ensure consistent SOP implementation training and understanding.
- Support updating QMS systems performing validation as necessary
- Identify develop and drive continuous improvement to quality system processes.
- Conduct and support internal audits CAPAs measure the effectiveness of the QMS
- Analyze and trend quality data for Quality Data Review and Management Review
- Participate in and support of external regulatory audits and inspections
- Maintain current knowledge of federal and international regulations (QSR/GMP ISO) as they relate to job responsibilities
- Represent the Quality function as a Subject Matter Expert (SME) of quality systems
- 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 inservices 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 drugfree workplace. We are an EqualOpportunity 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:
Unclear Seniority
Employment Type
Full Time
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