Quality Control Technician

Ready to Transform Your Career? Join SpiTrex 3D!

Are you looking to be part of a dynamic team in the cutting-edge world of additive manufacturing? Do you thrive in a fast-paced, growing environment that blends high technology and USA manufacturing? If so, we have the perfect opportunity for you!

We are a leading additive manufacturing company located in vibrant Carlsbad, California. Our innovative solutions are revolutionizing the industry, and we're seeking a talented Quality Assurance Associate to join our growing team. Imagine a workplace where your growth knows no bounds - where data drives success, and your career flourishes. We believe SpiTrex 3D is a workplace like no other. It is a place to be challenged, explore your curiosity, and grow your career.

Job Overview

As a Quality Control Technician I at SpiTrex 3D, this role is responsible for performing in-process and final inspections of 3D-printed components to ensure products consistently meet engineering specifications, customer requirements, and applicable regulatory standards. This position supports product quality through accurate inspection, documentation, and traceability while helping prevent nonconforming products from reaching customers.

Core Purpose of the Role:

• Ensure 3D-printed parts meet defined specifications through inspection, testing, and documentation.
• Prevent nonconforming products from reaching customers by executing standardized quality control processes.
• Support continuous improvement by identifying defects, recurring trends, and potential process gaps and communicating observations to Quality leadership.
• Maintain accurate and traceable records in accordance with ISO 13485, the FDA Quality Management System Regulation under 21 CFR Part 820, applicable customer requirements, and internal procedures.
• Verify dimensional, visual, and functional criteria against drawings, work instructions, and acceptance standards.

Essential Functions:

• Company Culture and Mission:

• • Consistently apply core values (Integrity, Impact, Dedication) to all decisions and interactions.
  • Uphold and reinforce the company's quality policy, operational discipline, and performance expectations.

• Final and In-Process Inspection and Release
  • Execute final and in-process dimensional and visual inspections in accordance with engineering drawings, control plans, work instructions, and acceptance criteria.
  • Document inspection acceptance and release product to the next authorized operation when all established acceptance criteria have been satisfied.
  • Place suspected nonconforming products on hold and escalate them in accordance with established procedures.

• Nonconformance Control
  • Identify, tag, and physically segregate suspected or nonconforming products to prevent unintended use.
  • Initiate Nonconforming Reports (NCRs) with clear defect descriptions, part and lot traceability, photographs, and measurement evidence.
  • Support nonconformance investigations and material segregation activities as needed.

• Measurement Systems and Equipment
  • Operate calipers, micrometers, height gauges, Keyence systems, and other specialty inspection equipment.
  • Verify the calibration status of inspection and measuring equipment before use and immediately report out-of-tolerance conditions.

• Documentation and Traceability
  • Maintain accurate inspection records, device history records, lot history records, travelers, and related quality documentation.
  • Ensure full traceability of parts, materials, tooling, and inspection results.

• Communication and Collaboration
  • Provide timely feedback to Production, Engineering, and Quality regarding defects, quality trends, and opportunities for improvement.
  • Participate in Quality Control meetings and collaborate with the team to identify opportunities for corrective actions, preventive measures, and improvements to product quality.

• Compliance

• • Ensure compliance with ISO 13485, FDA requirements, and internal procedures.
  • Maintain high standards of documentation accuracy, traceability, and professionalism in vendor and customer-facing deliverables.

Competencies:

• Understanding quality control principles and inspection techniques.
• Ability to read and interpret engineering drawings and specifications.
• Familiarity with mechanical testing and materials characterization.
• Problem-solving and troubleshooting skills.
• Ability to identify potential quality risks and escalate concerns appropriately.
• Strong organizational skills with close attention to detail.
• Strong commitment to safety and quality assurance.
• Ability to recognize when an inspection result or requirement is unclear and escalate the matter before releasing product.
• Ability to follow controlled procedures and standardized inspection methods consistently.
• Ability to maintain inspection independence and avoid accepting products based on schedule pressure.
• Ability to read and interpret engineering drawings, dimensional tolerances, and basic Geometric Dimensioning and Tolerancing (GD&T) requirements relevant to assigned inspections.

Education and Experience:

• Associate degree in a related field is preferred; or a high school diploma or equivalent with at least two years of relevant inspection, manufacturing quality, or technical experience.
• Experience in quality control in the medical device industry, aerospace, or automotive industry preferred.
• Experience with mechanical testing and materials characterization preferred.
• Experience with inspection equipment, such as calipers, micrometers, and height gauges preferred.

Physical Demands:

The employee is frequently required to remain stationary while performing inspections and documentation activities and must also move throughout production and inspection areas. The employee is regularly required to stand for extended periods, use hands and fingers to operate precision inspection equipment, and communicate with others to exchange information. The position requires sufficient visual acuity, with or without reasonable accommodation, to perform detailed visual and dimensional inspections.

Supervisory Responsibilities: This position has no direct reports or formal supervisory responsibilities. The Quality Control Technician I works under the direction of the Quality Control Supervisor and other designated Quality personnel. The role may communicate inspection results, quality concerns, and nonconforming conditions to Production, Engineering, Quality, and other appropriate personnel but does not assign work, evaluate employee performance, approve time, or make personnel decisions.

Location: Onsite position - This role is 100% onsite with no remote option.

Travel: N/A

Position Type and Expected Hours:

1st shift - Full-time - Monday to Friday: 8 AM to 5 PM or as adjusted. Occasional flexibility may be required to support operational needs.