Quality Manager

Quality Manager EyeKon Medical, Inc - 3.3 Clearwater, FL Job Details Full-time 21 hours ago Benefits Paid time off Qualifications ISO standards Compliance audits & assessments Manufacturing facility Training & development Root cause analysis FDA regulations Full Job Description Position Summary The Quality Manager is responsible for maintaining and improving the company's Quality Management System (QMS) to ensure compliance with FDA regulations, ISO 13485 standards, GMP requirements, and internal company procedures. This role focuses on quality systems, process control, documentation compliance, audit readiness, and continuous improvement across manufacturing operations. This position works cross-functionally with production, operations, and management teams to ensure product quality and regulatory compliance while supporting efficient manufacturing processes. Key Responsibilities Maintain and improve the company Quality Management System (QMS) Ensure compliance with FDA regulations, ISO 13485, GMP, and company quality standards Manage document control systems, including SOPs, work instructions, forms, and records Lead CAPA activities, non-conformance investigations, and root cause analysis Coordinate internal audits, supplier audits, and external regulatory inspections Monitor quality metrics and identify opportunities for process improvement Ensure proper implementation and maintenance of quality procedures throughout production Review and maintain production and quality documentation for accuracy and compliance Support validation activities, risk management, and change control processes Assist with employee training related to quality procedures and compliance requirements Collaborate with operations and production teams to improve efficiency while maintaining compliance Maintain audit readiness and support regulatory submissions or inspections as needed Qualifications Bachelor's degree preferred in Quality, Engineering, Life Sciences, Manufacturing, or related field 3-5 years of experience in quality systems or regulated manufacturing environments Strong knowledge of FDA regulations, GMP, and

ISO 13485

requirements Experience with CAPA, document control, audits, and quality systems management Strong organizational and analytical skills Excellent communication and problem-solving abilities Proficiency in Microsoft Office and quality management software Preferred Qualifications Medical device manufacturing experience preferred Internal Auditor certification a plus Experience with risk management and process improvement initiatives Physical & Workplace Requirements Combination of office and manufacturing floor environment Must comply with all company safety and production attire requirements, including PPE and approved workplace clothing Ability to stand and walk through production areas as needed Compensation Compensation is commensurate with experience, qualifications, and relevant industry background.

Benefits:

Paid time off

Work Location:

In person