Principal Quality Engineer Technician

Position Overview

The Principal Quality Engineering Technician serves as the site technical lead for inspection, test, and laboratory equipment used to verify product quality in a regulated medical device manufacturing environment. This position provides advanced hands-on support for Coordinate Measuring Machines (CMMs), X-ray inspection systems, dye penetrant testing equipment, metallography preparation/analysis equipment, and related QC equipment and software.

Responsibilities

• Serve as the site subject matter expert (SME) for CMM inspection systems, including programming, troubleshooting, method optimization, routine maintenance coordination, fixture support, and program control.
• Develop, validate, revise, and maintain CMM programs using ZEISS CALYPSO or equivalent software to support production inspection, first article inspection, process validation, capability studies, investigations, and engineering development activities.
• Program, configure, troubleshoot, and support X-ray inspection equipment and related software for product inspection, defect evaluation, measurement, and documentation activities.
• Interpret complex engineering drawings, specifications, and models using GD&T principles to establish appropriate inspection strategies, datum structures, tolerancing approaches, and measurement methods.
• Support QC equipment used for CMM, X-ray, dye penetrant testing, metallography, optical/vision inspection, dimensional inspection, and other laboratory or production inspection processes.
• Perform or coordinate routine equipment checks, preventive maintenance, troubleshooting, service calls, and vendor support for QC inspection and test equipment.
• Support equipment qualification, installation, operational, and performance qualification activities, including authoring or executing protocols, documenting deviations, and analyzing results.
• Develop, revise, and maintain inspection methods, work instructions, equipment operating procedures, test protocols, forms, and other quality documentation associated with QC equipment and inspection processes.
• Perform measurement system analysis activities, including Gage R&R, method comparisons, repeatability/reproducibility assessments, bias studies, and capability evaluations as needed.
• Investigate nonconformances; identify technical root causes; and partner with cross-functional teams to implement effective corrective and preventive actions.
• Provide technical support for internal and external audits, regulatory inspections, and customer or supplier inquiries related to QC equipment, inspection methods, and quality records.
• Collaborate with Engineering, Manufacturing, Maintenance, Metrology/Calibration, and external equipment manufacturers or service providers to sustain and improve inspection processes, equipment uptime, and key performance indicators.
• Identify and implement improvements to inspection programs, fixtures, equipment setup, data collection, reporting, and workflow to improve accuracy, throughput, compliance, and reduction of inspection-related waste.
• Train and mentor inspectors, technicians, and cross-functional personnel on QC equipment operation, CMM and X-ray inspection practices, and GD&T interpretation.
• Support calibration planning, equipment status review, out-of-tolerance assessments, and impact evaluations for QC inspection and laboratory equipment.
• Maintain inspection program revision control, electronic data integrity, equipment files, software backups, and related documentation in accordance with QMS requirements.
• Provide escalation support for complex technical quality issues on the manufacturing floor and in QC laboratory areas.

Qualifications

• Associate’s degree in engineering technology, Metrology, Quality, Manufacturing, Materials Science, or related technical field preferred. Equivalent combination of education, training, and directly relevant experience may be considered.
• Typically 8+ years of experience in Quality, Metrology, Inspection, Manufacturing Engineering, or related technical roles, preferably in a regulated medical device, aerospace, automotive, pharmaceutical, or other highly regulated manufacturing environment.
• Advanced CMM programming experience required; hands-on experience with ZEISS CALYPSO strongly preferred.
• Experience supporting CMM equipment maintenance, troubleshooting, service coordination, probe qualification, fixture verification, and inspection program management required.
• Experience programming, operating, or supporting industrial X-ray inspection equipment and software strongly preferred.
• Strong working knowledge of GD&T and dimensional inspection methods required; ability to interpret complex drawings, specifications, models, datums, and tolerance schemes.
• Experience with dye penetrant testing, metallography sample preparation/evaluation, microscopy, hardness testing, optical/vision systems, or other QC laboratory equipment preferred.
• Knowledge of equipment qualification, process validation, inspection method validation, calibration, Gage R&R, MSA, capability analysis, and statistical problem-solving tools preferred.
• Workplace knowledge of FDA Quality System Regulation, ISO 13485, cGMP/GDP expectations, document control, data integrity, and medical device QMS requirements preferred.
• Demonstrated ability to lead complex technical troubleshooting, mentor others, communicate across functions, and drive sustainable improvements without direct supervision.
• Proficiency with quality records, technical report writing, inspection data analysis, Microsoft Office applications, and electronic quality or document management systems.
• PREFERRED CERTIFICATIONS OR TRAINING INCLUDE: ASQ CQT/CQE/CCT or equivalent quality/metrology certification; formal training in ZEISS CALYPSO, GD&T, X-ray inspection, dye penetrant testing, metallography, or applicable nondestructive testing methods.