Quality Assurance Specialist

3 weeks ago


Conshohocken, Pennsylvania, United States Extremity Care Full time
Job Overview

The Quality System Engineer at Extremity Care plays a pivotal role in ensuring the operational compliance of our quality system. This position is responsible for verifying that all products and services meet established quality standards, guaranteeing exceptional patient care and satisfaction.

About Us
Extremity Care is a leading healthcare provider dedicated to delivering cutting-edge treatments and technologies to patients worldwide. Our team of experts is passionate about improving lives through innovative solutions and compassionate care.

Key Responsibilities
• Initiate and lead investigations into quality-related events, ensuring prompt and effective resolution
• Coordinate and execute training programs, retraining, and corrective/preventive actions associated with quality events
• Track and trend quality events to identify areas for improvement
• Support supplier qualifications and internal/external audits to ensure regulatory compliance
• Develop and revise procedures/controlled documents according to FDA, AATB, and other applicable regulations
• Review quality control records, including equipment maintenance, environmental monitoring, and supply inspections
• Perform tracking and trending of Environmental Monitoring Results in accordance with standard operating procedures
• Author/review standard operating procedures in accordance with relevant regulations/standards and internal organizational policies

Requirements
• Bachelor's degree in biological science, engineering, or related field from an accredited institution
• 2-4 years of experience in an FDA-regulated environment for HCT/Ps, medical devices, pharmaceuticals, and/or related field
• 1 year of experience in conducting quality investigations and/or audits preferred
• Clearance of favorable background investigation required

Compensation and Benefits
We offer a highly competitive salary range of $63,000 - $71,000 annually, depending on experience. Additionally, we provide a comprehensive benefits package, including health insurance, retirement plan, and paid time off.

Work Environment
Our office is located in a dynamic and supportive environment, promoting collaboration and innovation. As a Quality System Engineer, you will work closely with our cross-functional teams to drive quality excellence and patient satisfaction.

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