Quality Assurance & Compliance Coordinator

Qosina Corp.; Town of Islip (NY); On-site; USD 37,000 - 39,000; Full time

Job summary

Qosina Corp. in Ronkonkoma, NY seeks a Quality Coordinator to support QA/QC activities, ensuring compliance with ISO 13485, ISO 9001 and 21 CFR Parts 820, 210, 211.

This full-time, non-exempt role reports to Quality Department Management and involves data integrity, product quality improvements, and regulatory readiness. You will analyze issues, coordinate audits, maintain ERP records, respond to customer inquiries, and drive CAPAs with root-cause analyses.

Qualifications

• Associate degree or equivalent preferred.
• Experience in QA/QC.
• Familiarity with ISO 13485, ISO 9001 and 21 CFR Parts 820, 210, 211 is a plus.
• Proficient in MS Office.

Responsibilities

• Assist with quality-related activities and projects as directed by the Quality Assurance Manager.
• Analyze and investigate to improve product quality and processes.
• Respond to customer inquiries regarding product specifications and the quality management system.
• Ensure products meet established quality and regulatory standards, including reliability, usability, performance, and safety.
• Collaborate with teams and committees to maintain organizational quality standards.
• Maintain accurate and up-to-date information in the ERP system.
• Collect and organize material and product documentation to support regulatory requirements.
• Review customer specifications for accuracy.
• Create, revise, and release product drawings as needed.
• Assist in coordinating and releasing product Change Notifications.
• Communicate with management to address and resolve issues.
• Recommend and implement improvements to operational methods and practices.
• Investigate customer complaints and non-conformance issues, responding to requests for information as necessary.
• Participate in corrective and preventive actions, including root cause analysis.
• Conduct internal audits of management systems per the audit schedule.
• Support external audits conducted by customers and regulatory bodies.

Skills

Quality Assurance

Quality Control

Data analysis

MS Excel

Documentation

Audit coordination

Education

Associate degree or equivalent

Tools

MS Excel

ERP systems

Job description

Qosina Corp. in Ronkonkoma, NY seeks a Quality Coordinator to support QA/QC activities, ensuring compliance with ISO 13485, ISO 9001 and 21 CFR Parts 820, 210, 211.

This full-time, non-exempt role reports to Quality Department Management and involves data integrity, product quality improvements, and regulatory readiness. You will analyze issues, coordinate audits, maintain ERP records, respond to customer inquiries, and drive CAPAs with root-cause analyses.