Hybrid Quality & Regulatory Specialist

Cook Medical Inc.; Poway (CA); Hybrid; USD 52,000 - 58,000; Full time

Job summary

K-Tube Technologies is seeking a Quality and Regulatory Specialist to manage quality system processes, handle customer complaints, CAPAs, regulatory requests, audits, and calibration tasks. The role collaborates with internal teams, suppliers, and auditors to ensure compliant handling and timely escalation.

This position develops technical knowledge to support Quality Engineer responsibilities. Under limited supervision, you will support the QMS, drive improvements, and back up selected

Qualifications

• Associate degree in Quality, Engineering Technology, Manufacturing Technology, Industrial Technology, Science, or a related field.
• Minimum 3 years experience in a Manufacturing or Quality environment.
• Proficient with MS Word, Excel, Power Point, Outlook.

Responsibilities

• Reviews customer complaints and RA requests to determine handling and escalation.
• Coordinates investigations, corrective actions, responses, and documentation; tracks progress.
• Supports root cause investigations and continuous improvement activities.
• Reviews customer surveys, quality agreements, and regulatory requests.
• Coordinates PPAPs, first article documentation, certifications, and related submissions.
• Maintains and reviews customer quality and regulatory records.
• Coordinates Quality Management System review activities and audits.
• Schedules and documents calibration activities and tracks overdue items.
• Provides backup support for designated Quality Engineer responsibilities.

Skills

Quality systems

Quality principles

Communication skills

MS Word

Excel

PowerPoint

Outlook

Education

Associate degree in Quality or related field

Tools

MS Office Suite

Job description

K-Tube Technologies is seeking a Quality and Regulatory Specialist to manage quality system processes, handle customer complaints, CAPAs, regulatory requests, audits, and calibration tasks. The role collaborates with internal teams, suppliers, and auditors to ensure compliant handling and timely escalation.

This position develops technical knowledge to support Quality Engineer responsibilities. Under limited supervision, you will support the QMS, drive improvements, and back up selected