QC Technician

QC Technician

Department: Quality FLSA Status: Non-Exempt Location: WillowWood West – Mesa, Arizona

Position Summary

The QA/QC Technician is responsible for supporting the quality management system through

incoming, in-process, and final inspections of prosthetic feet, foot components, machined parts, and related materials. This position works closely with Production, Engineering, and Supply Chain to ensure products meet established quality standards, customer requirements, and ISO 13485 regulatory requirements.

The QA/QC Technician supports receiving inspections, product traceability, traveler management, work instruction maintenance, employee training, nonconformance investigations, returns processing, and validation activities. This role plays a critical part in ensuring the quality and consistency of products manufactured at WillowWood West.

Essential Responsibilities

Inspection & Quality Control

• Perform incoming, in-process, and final inspections of raw materials, machined components, subassemblies, and finished prosthetic products.
• Verify product conformance to drawings, specifications, work instructions, and quality standards.
• Utilize measurement equipment including calipers, micrometers, gauges, indicators, and other inspection tools.
• Document inspection results and maintain quality records in accordance with established procedures.
• Identify, document, and segregate nonconforming materials and products.
• Assist with root cause investigations and corrective actions related to quality issues.

Receiving & Incoming Inspection

• Conduct receiving inspections of raw materials, purchased components, and outside processed parts.
• Verify incoming materials meet applicable specifications and purchasing requirements.
• Review certifications, documentation, and inspection records for completeness and compliance.
• Support material traceability and product identification requirements.

Traveler & Documentation Management

• Create, review, update, and maintain production travelers.
• Verify manufacturing documentation is complete, accurate, and properly maintained.
• Assist with document control activities, including revisions to Work Instructions (WI), Standard Operating Procedures (SOPs), forms, and quality documents.
• Ensure current revisions are available and utilized throughout production.

Training Support

• Assist with training employees on quality requirements, inspection methods, work instructions, and documentation procedures.
• Support training record maintenance and training effectiveness verification.
• Communicate quality-related process changes to affected personnel.

Returns, Nonconformance & Corrective Actions

• Process returned products and materials in accordance with quality procedures.
• Support investigations related to customer complaints, product returns, and nonconforming materials.
• Assist with corrective and preventive action (CAPA) activities.
• Track and maintain records related to quality events and dispositions.

Validation & Continuous Improvement

• Support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for equipment, processes, and manufacturing changes.
• Assist Engineering and Quality personnel with validation documentation and record retention.
• Participate in internal audits and continuous improvement initiatives.
• Recommend process improvements that enhance product quality, efficiency, and compliance.

General Responsibilities

• Maintain a safe, clean, and organized work environment.
• Follow all company safety, quality, and regulatory requirements.
• Support ISO 13485 Quality Management System requirements.
• Perform other duties as assigned.

Essential Skills & Qualifications

• High school diploma or equivalent required; Associate degree or technical certification preferred.

• Minimum 2 years of experience in quality inspection or a related quality-focused role preferred.

• Experience in machining, medical device manufacturing, or regulated manufacturing environments preferred.
• Ability to read and interpret engineering drawings, specifications, and manufacturing documentation.
• Proficiency with inspection tools including calipers, micrometers, height gauges, and other measurement equipment.
• Strong attention to detail and documentation skills.
• Basic computer proficiency including Microsoft Office applications.
• Strong organizational, analytical, and problem-solving skills.
• Ability to work independently and collaboratively in a team environment.
• Knowledge of ISO 13485, CAPA, and quality system requirements preferred.

Physical Requirements

• Frequent standing, walking, bending, and reaching throughout the workday.
• Frequent use of hands and fingers for inspection and measurement activities.
• Ability to lift and carry materials, fixtures, and components up to 30 pounds.
• Ability to perform detailed visual inspections, including close vision, color differentiation, depth perception, and focus adjustment.

Work Environment

• Manufacturing and machine shop environment.
• Regular exposure to production equipment, machining operations, and assembly processes.
• Exposure to moderate manufacturing noise levels.
• Required use of appropriate personal protective equipment (PPE) within designated work areas.