Quality Assurance Specialist (Remote)

React Health; Chicago (IL); Remote; USD 60,000 - 90,000; Full time

Job summary

An innovative company is seeking a Quality Assurance Specialist to join its dynamic team. This role is essential in ensuring compliance and quality within the medical equipment sector. You will engage in document control, analyze quality data, and support regulatory audits, all while collaborating with cross-functional teams. If you are detail-oriented and have a passion for quality assurance in healthcare, this position offers a unique opportunity to make a significant impact in a fast-paced environment. Join a forward-thinking organization committed to excellence and patient care.

Qualifications

• Minimum of a bachelor's degree in engineering or life sciences required.
• Experience with FDA regulations and ISO standards is essential.

Responsibilities

• Perform document control and CAPA coordination.
• Analyze quality data and support internal audits.
• Ensure compliance with QMS documents and procedures.

Skills

Document Control

Quality Data Analysis

Project Management

Regulatory Compliance

Cross-Functional Team Collaboration

Education

Bachelor's Degree in Engineering

Bachelor's Degree in Life Sciences

Job description

Position:Quality Assurance Specialist (Remote)

Location: Dublin, OH

Job Id:630

# of Openings:1

POSITION: Quality Assurance Specialist

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 acute-care, non-acute 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

• A minimum of a bachelor's 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

• Bachelor’s degree in engineering, life sciences or related field
• Preferred Experience
• 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, 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.