Highlights
Must have 2 plus years of experience in Quality Assurance, Product Complaints, Investigations, or a similar role in an FDA-regulated medical device or life sciences setting. Quality Assurance Specialist will be responsible for but not limited to the following: Receive, document, investigate, and close customer product complaints in accordance with company procedures and regulatory requirements.
Numbers & Facts
| Location | Jacksonville, FL |
| Industry | Healthcare Services |
| Company Size | 500 to 999 employees |
| Year Founded | 2017 |
| Website | http://www.quadrantinc.com/ |
Description
Quality Assurance Specialist
Jacksonville, Florida
Pay From: $21.00 per hour
MUST:
Experienced Quality Assurance Specialist
Must have 2 plus years of experience in Quality Assurance, Product Complaints, Investigations, or a similar role in an FDA-regulated medical device or life sciences setting
Must have strong analytical and problem-solving skills
Must be proficient in Microsoft Office, with strong Excel
Must be able to multi-task in a fast-paced environment
Knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, and ISO 14971 is highly preferred
Bachelor s degree highly preferred
DUTIES:
Quality Assurance Specialist will be responsible for but not limited to the following:
Receive, document, investigate, and close customer product complaints in accordance with company procedures and regulatory requirements
Maintain accurate complaint records and ensure timely documentation within the Quality Management System (QMS)
Conduct product complaint investigations, including reviewing production records, test results, and other relevant documentation to determine root cause
Perform complaint assessments to support regulatory reporting and product risk evaluations
Monitor and analyze complaint data to identify trends and recommend quality improvements
Partner with Quality, Regulatory, Manufacturing, R&D, and Customer Care to support investigations, corrective actions (CAPA), and continuous improvement initiatives
Maintain audit-ready documentation and assist with internal and external quality audits.
Protect confidential patient information and ensure compliance with privacy and quality requirements
Provide excellent customer service and support to customers and patients as needed
Support ongoing improvements to quality systems, procedures, and processes
Perform other duties as assigned
Quadrant is an affirmative action/equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, status as a protected veteran, or status as an individual with a disability. Healthcare benefits are offered to all eligible employees according to compliance mandated by the Affordable Care Act .
Jacksonville, Florida
Pay From: $21.00 per hour
MUST:
Experienced Quality Assurance Specialist
Must have 2 plus years of experience in Quality Assurance, Product Complaints, Investigations, or a similar role in an FDA-regulated medical device or life sciences setting
Must have strong analytical and problem-solving skills
Must be proficient in Microsoft Office, with strong Excel
Must be able to multi-task in a fast-paced environment
Knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, and ISO 14971 is highly preferred
Bachelor s degree highly preferred
DUTIES:
Quality Assurance Specialist will be responsible for but not limited to the following:
Receive, document, investigate, and close customer product complaints in accordance with company procedures and regulatory requirements
Maintain accurate complaint records and ensure timely documentation within the Quality Management System (QMS)
Conduct product complaint investigations, including reviewing production records, test results, and other relevant documentation to determine root cause
Perform complaint assessments to support regulatory reporting and product risk evaluations
Monitor and analyze complaint data to identify trends and recommend quality improvements
Partner with Quality, Regulatory, Manufacturing, R&D, and Customer Care to support investigations, corrective actions (CAPA), and continuous improvement initiatives
Maintain audit-ready documentation and assist with internal and external quality audits.
Protect confidential patient information and ensure compliance with privacy and quality requirements
Provide excellent customer service and support to customers and patients as needed
Support ongoing improvements to quality systems, procedures, and processes
Perform other duties as assigned
About Company
Quadrant is a full-life cycle staff augmentation agency providing a proven "rapid fire" approach in responding to the needs of our clients. Quadrant offers a comprehensive suite of staffing solutions for organizations in the Healthcare, Medical, Dental, Information Technology, HR and Government contract sectors.
Our clients have come to include some of the largest and most recognized brand named companies in the Washington, DC and Baltimore, MD metropolitan regions. Quadrant is a DOD TOP Secret cleared facility and holds a Maryland Minority Business Enterprise (MBE) and Virginia SWaM certification. Quadrant's clients are rapidly hiring a mix of healthcare, medical, dental, information technology, recruiting and HR professionals.
Quadrant is recognized as the largest Healthcare Staffing agency in the Washington DC area. We support every major healthcare system and thousands of area healthcare practices. Our healthcare division focuses on all clinical and nonclinical staff with the exception of physicians. Our database boasts hundreds of thousands of local screened healthcare professionals; the largest in the area. Our resources enable us to respond to our clients requests quickly, generally within 24 hours of request on mainstream orders.
Our Information Technology clients support a broad mix of commercial and federal government agencies. Our clients include government contractors who support projects with federal agencies such as U.S. Department of Veterans Affairs, National Institutes of Health(NIH), U.S. Customs and Border Patrol, FDA, FBI, USPTO, DHS, DHHS, DOD, DOJ, DOE, DISA, and USPS. In addition to our federal portfolio, Quadrant also supports a range of commercial clients focusing in software, telecom, mobile, web and healthcare development.
Whether you are a job seeker or a company with open positions to fill we will bridge the talent gap. Contact any of our seasoned professional recruiters or account managers and we will walk you through our proven staffing methodology. We offer a consultative approach to both potential employee and employer. We seek the right match, at the right time, every time.
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