Calibration Technician I, QC

$54,080 - $64,480/Yr

Alphatec Spine - Carlsbad, CA

Full-time - Entry Level

Carlsbad, CA

Merchant Wholesalers, Durable Goods

About the position

The Calibration Technician I position at Alphatec Spine is responsible for supporting the Calibration System to ensure that inspection tools, test equipment, and custom gauging are properly calibrated and documented. This role requires effective communication with the Calibration team to ensure compliance with company procedures, ISO 13485 standards, and CFR Title 21 part 820 regulations.

Responsibilities

• Accurately prepare and maintain calibration records on all tools and inspection equipment requiring calibration.
• Perform calibration, traceable to NIST, on tools such as calipers, micrometers, height gauges, hard gauges, and indicators.
• Perform calibrations on custom gauging utilizing hand tools, tabletop instruments, and/or vision systems.
• Work with outside calibration contractors on calibration requirements, calibration reports, gauge drawings, etc.
• Perform production lot inspections to support QC inspection as needed.
• Maintain and control the Calibration System to ensure compliance with Alphatec's procedures, ISO 13485, and CFR Title 21 Part 820 regulations.
• Serve as a point of contact for coordination and resolution of out-of-tolerance and out-of-repair conditions.
• Analyze data using Smart Profile as needed to support calibration.
• Log and maintain accurate calibration information in the calibration database.
• Issue monthly calibration schedules identifying tools and equipment that are due for calibration.
• Help develop and support ways to manage cost and improve the calibration system.
• Read, understand, and interpret engineering drawings (blueprints) and associated GD&T (Geometric Dimension & Tolerancing).
• Perform complex mechanical, visual, and functional inspection as needed.

Requirements

• High School Diploma or equivalent.
• 3+ years experience with direct hands-on mechanical inspection of precision machined parts; experience working in a Quality Assurance or Quality Control capacity; medical device industry experience strongly desired.
• Good communication skills, both verbal and written.
• Strong organization skills and attention to detail.
• Basic math and computer skills required.
• Understanding of calibration principles.
• Advanced experience using equipment such as vision systems, super micrometers, height gauges, comparator, and pin gauges.
• Ability to read and interpret engineering drawings.
• Strong understanding of GD&T.
• Working knowledge of 21 CFR (Code of Federal Regulations), Part 820 and ISO 13485.

Nice-to-haves

• Prior Calibration Technician (or equivalent) experience preferred but not required.