Quality & Regulatory Specialist — Hybrid, CAPA & Audits

americas-cookmedical; Poway (CA); Hybrid; USD 52,000 - 58,000; Full time

Job summary

K-Tube Technologies in Poway, CA is seeking a Quality and Regulatory Specialist to manage the quality system processes, including customer complaints, CAPA, regulatory requests, audits, and calibration coordination. This role develops technical knowledge to support Quality Engineer responsibilities and collaborates with customers, suppliers, and internal departments.

The position requires an Associate degree and at least 3 years in manufacturing QA, with strong communication skills and

Qualifications

• Associate degree in Quality, Engineering Technology, Manufacturing Technology, Industrial Technology, Science, or a related field required.
• Minimum 3 years experience in a Manufacturing or Quality environment.
• Working knowledge of quality systems and quality principles.
• Proficient with MS Word, Excel, PowerPoint, and Outlook.

Responsibilities

• Reviews customer complaints and RA requests to determine handling and escalation, coordinates activities through closure.
• Coordinates investigations, corrective actions, responses, and supporting documentation; tracks progress and due dates.
• Supports root cause investigations and continuous improvement activities.
• Reviews customer surveys, quality agreements, and regulatory requests to determine handling and escalation needs.
• Prepares responses within guidelines and coordinates input from internal stakeholders for timely communications.
• Coordinates PPAPs, first article documentation, certifications, and related customer submissions.
• Maintains and reviews customer quality and regulatory records for compliance.
• Coordinates Quality Management System review activities and audits, tracks action items to completion.
• Maintains controlled quality records and coordinates document review and approvals.
• Schedules calibration activities and tracks overdue items to ensure equipment calibration.
• Supports validation, investigation, risk assessment, and quality improvement projects.
• Reviews drawings, specifications, and quality data to support activities.

Job description

K-Tube Technologies in Poway, CA is seeking a Quality and Regulatory Specialist to manage the quality system processes, including customer complaints, CAPA, regulatory requests, audits, and calibration coordination. This role develops technical knowledge to support Quality Engineer responsibilities and collaborates with customers, suppliers, and internal departments.

The position requires an Associate degree and at least 3 years in manufacturing QA, with strong communication skills and