Cook Group is a family-owned network of entrepreneurial companies rooted in medical devices and healthcare. Based in Indiana with operations spanning a global footprint, the organization works across life sciences, property management, resorts, services, consulting, and logistics. Its businesses are guided by integrity, quality, respect, and transparency, with an emphasis on developing practical solutions for employees, customers, and the communities they serve.
Quality and Regulatory Specialist – Poway Hybrid
Support K-Tube’s manufacturing quality systems for miniature stainless steel tubing. Manage complaints, audits, corrective actions, regulatory requests, records, and calibration activities.
Description
- Administer assigned processes within K-Tube’s Quality Management System
- Evaluate customer complaints and return authorization requests, determine escalation, and coordinate resolution through closure
- Coordinate investigations, corrective actions, responses, records, status updates, commitments, and deadlines
- Assist with root-cause investigations and continuous improvement initiatives
- Review customer surveys, quality agreements, and regulatory inquiries; draft responses and gather stakeholder input
- Coordinate PPAPs, first-article records, certifications, and other customer submissions
- Maintain customer quality and regulatory documentation
- Organize Quality Management System reviews, management reviews, quality meetings, action tracking, and commitments
- Maintain controlled quality records and coordinate document review and approval workflows
- Coordinate internal, customer, and certification audits, tracking findings and corrective actions to closure
- Schedule and document calibration activities and monitor overdue work
- Assist with validation, investigations, risk assessments, and quality improvement projects
- Review engineering drawings, specifications, and quality data
- Build technical knowledge of K-Tube products, materials, manufacturing processes, and quality systems
- Provide backup coverage for assigned Quality Engineer duties
- Provide inspection backup during absences, workload peaks, or investigations
- Report to the Quality and Regulatory Engineering Manager
Requirements
- An associate degree in Quality, Engineering Technology, Manufacturing Technology, Industrial Technology, Science, or a related discipline is required; relevant manufacturing quality experience may substitute for the degree
- At least 3 years of experience in a manufacturing or quality setting
- Working knowledge of quality systems and quality principles
- General familiarity with customer complaints, CAPA, root-cause investigations, audits, document control, calibration, and validation
- Strong written and verbal communication skills
- Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook
- Ability to manage multiple projects and assignments in a fast-paced environment
- Ability to lift up to 10 pounds
- Ability to sit or stand, reach, and move throughout the facility
- Must be legally authorized to work in the United States; employment visa sponsorship is unavailable
Benefits
- Hybrid work arrangement
- Business-casual workplace
- Equal employment opportunity protections