Quality and 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

Overview

K-Tube Technologies manufactures made to order miniature stainless steel tubing for use in medical, automotive, aerospace, and industrial applications. Under limited supervision, the Quality and Regulatory Specialist manages assigned quality system processes and supports K-Tube's Quality Management System through customer complaints, corrective actions, regulatory and compliance requests, audits, return authorizations, calibration, and related quality activities. The role works closely with internal departments, customers, suppliers, and auditors to determine appropriate handling of quality matters, coordinate and prioritize assigned activities, drive quality activities through completion, and identify issues requiring escalation. Through these responsibilities, the position develops the technical knowledge and experience needed to support and back up selected Quality Engineer responsibilities.

Overview

K-Tube Technologies manufactures made to order miniature stainless steel tubing for use in medical, automotive, aerospace, and industrial applications. Under limited supervision, the Quality and Regulatory Specialist manages assigned quality system processes and supports K-Tube's Quality Management System through customer complaints, corrective actions, regulatory and compliance requests, audits, return authorizations, calibration, and related quality activities. The role works closely with internal departments, customers, suppliers, and auditors to determine appropriate handling of quality matters, coordinate and prioritize assigned activities, drive quality activities through completion, and identify issues requiring escalation. Through these responsibilities, the position develops the technical knowledge and experience needed to support and back up selected Quality Engineer responsibilities.

Pay Range:

$38.00 - $42.00 per hour

Responsibilities

Customer Complaints, Corrective Actions, and RA’s

• Reviews customer complaints and RA requests to determine appropriate handling and escalation, communicates with customers and internal stakeholders, and coordinates complaint activities through closure.
• Coordinates investigations, corrective actions, responses, and supporting documentation; tracks progress, commitments, and due dates to support timely resolution.
• Supports root cause investigations and continuous improvement activities.

Customer and Regulatory Support

• Reviews customer surveys, quality agreements, and regulatory requests to determine appropriate handling, required information, and escalation needs.
• Prepares responses within established guidelines and coordinates input from internal stakeholders to support timely and accurate customer communications.
• Coordinates PPAPs, first article documentation, certifications, and related customer submissions.
• Maintains and reviews customer quality and regulatory records to support compliance and customer requirements.

Quality Systems and Audits

• Coordinates Quality Management System review activities, including management reviews and quality meetings, gathers information from multiple departments, and tracks action items and commitments through completion.
• Maintains controlled quality records and coordinates document review and approval activities.
• Coordinates internal, customer, and certification audits, reviews supporting documentation, works with process owners to address audit requests, and tracks findings and corrective actions through closure.
• Schedules, coordinates and documents calibration activities with internal and external parties, reviews calibration status, and tracks overdue activities to ensure equipment remains in calibration.

Quality Engineering Support

• Supports validation, investigation, risk assessment, and quality improvement projects.
• Reviews drawings, specifications, and quality data to support assigned activities.
• Develops technical expertise in K-Tube products, materials, manufacturing processes, and quality systems.
• Provides backup support for designated Quality Engineer responsibilities as experience and training permit.

Inspection Support

• Provides backup inspection support during absences, workload fluctuations, or investigations.
• Maintains working knowledge of inspection methods and quality requirements.

Qualifications

Education and Experience:

• Associate degree in Quality, Engineering Technology, Manufacturing Technology, Industrial Technology, Science, or a related field required. Relevant manufacturing quality experience may be considered in place of the degree
• Minimum 3 years experience in a Manufacturing or Quality environment.

Job Knowledge, Skills And Abilities

• Working knowledge of quality systems and quality principles.
• General understanding of customer complaints, CAPA, root cause investigation, auditing, document control, calibration, and validation.
• Approachable, inquisitive, and relates well to all kinds of people.
• Must have good communication skills, both written and spoken.
• Must be proficient with MS Word, Excel, Power Point, Outlook
• Ability to thrive in a fast paced environment, managing multiple projects and assignments simultaneously.

Physical Requirements

• Must be able to lift to 10 pounds
• Light physical effort required
• Regularly required to sit or stand, reach and move about the facility

Work environment

• Work performed in both a manufacturing and office environment
• Minimal exposure to metals, lubricants, solvents, electrolytes and other hazardous materials
• Professional environment requiring business casual attire

Personal Protective Equipment

• Other personal safety equipment required as listed in SDS depending on task may include safety goggles, ear protection, full - face shield, apron, arm guards, rubber boots and gloves.

Position Type

Hybrid –– typically requires three days per week in the office and additional days as necessary

Status:

Full Time/Non Exempt

Reports to:

Quality and Regulatory Engineering Manager

Qualified candidates must be legally authorized to be employed in the United States, K-Tube does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this position.