Quality & Regulatory Compliance Specialist

Cook Group; 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, respond to customer complaints, regulatory requests, audits, calibration, and CAPA activities in a hybrid environment. This role partners with internal teams, customers, suppliers, and auditors to drive improvements, maintain compliance, review documentation, and support quality engineering duties as needed.

Requires an associate degree and at least three years in manufacturing quality.

Qualifications

• Associate degree required or equivalent manufacturing quality experience.
• Minimum 3 years in a manufacturing or quality environment.
• Working knowledge of quality systems and quality principles.

Responsibilities

• Reviews customer complaints and RA requests and coordinates activity through closure.
• Coordinates investigations, corrective actions, and supporting documentation.
• Supports root cause investigations and continuous improvement activities.
• Reviews customer surveys, quality agreements, and regulatory requests.
• Coordinates PPAPs, first article documentation, and related submissions.
• Maintains and reviews customer quality and regulatory records.
• Coordinates audits and documents calibration activities.

Skills

Quality systems knowledge

CAPA

Root cause investigation

Auditing

Document control

Calibration

Communication skills

MS Office

Education

Associate degree in Quality/Engineering Technology/Manufacturing Technology

Tools

MS Office Suite

Job description

K-Tube Technologies is seeking a Quality and Regulatory Specialist to manage quality system processes, respond to customer complaints, regulatory requests, audits, calibration, and CAPA activities in a hybrid environment. This role partners with internal teams, customers, suppliers, and auditors to drive improvements, maintain compliance, review documentation, and support quality engineering duties as needed.

Requires an associate degree and at least three years in manufacturing quality.