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Overview

Company

Original Job Post

React Health · 4 days ago

Quality Assurance Specialist II

Sarasota, FL

Full-time

Remote

Entry, Mid Level

2+ years exp

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Responsibilities

Perform change orders and assigned associated training in accordance with procedures

Ensure QMS documents are processed in a timely manner according to procedure

Ensure 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, NCs, measure the effectiveness of the QMS

Analyze and trend quality data for Quality Data Review and Management Review

Participate in and support external regulatory audits and inspections

Support compliance by performing Medical Device Tracking activities, as needed

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

Attend and participate in departmental meetings. Attend seminars and training sessions necessary to maintain an appropriate level of professional competence

Ensure all department compliance guidelines are met

Attend all meetings, in-services training, or continuing education as delegated by the supervisor

Provide customer-focused interactions

Perform all duties necessary for the department as per department policies and procedures

Perform other duties and responsibilities as delegated by the supervisor within the scope of practice and the responsibilities in the department

Qualification

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FDA RegulationsISO 13485 2016Project ManagementProblem-SolvingRelationship BuildingTime ManagementMedical device industry knowledgeAttention to detailCommunicationInterpersonal skills

Required

A minimum of an associate degree in engineering, life sciences +2 years of experience in a related position, required; 3 years of experience will be considered in lieu of degree.

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