Quality Assurance Specialist

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".