Principal Quality Engineer Technician

Company Overview:

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. specializes in developing innovative medical devices aimed at addressing challenging cardiac and vascular conditions. Our Austin facility houses a diverse team dedicated to producing the On-X Mechanical Heart Valves. With over 1,600 employees globally and manufacturing sites in Atlanta, Austin, and Hechingen, Germany, Artivion serves healthcare professionals in over 100 countries. For more details, visit our website at www.artivion.com.

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.

The role is responsible for developing and maintaining inspection programs, troubleshooting and sustaining QC equipment, supporting equipment qualification and calibration activities, and ensuring inspection methods are compliant, repeatable, and aligned with engineering drawings, GD&T requirements, internal procedures, and applicable regulatory standards.

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.
• Working 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.

Benefits & Perks:

We offer a comprehensive and competitive benefits package designed to support your health, financial well-being, and work-life balance:

• Generous Time Off: Enjoy 5 weeks of Paid Time Off (PTO), accrued throughout the year, plus 10 paid company holidays
• Health & Wellness: Comprehensive medical, dental, and vision coverage, along with life insurance and supplemental benefits
• Retirement Planning: 401(k) with up to a 4% company match (Traditional and Roth options available)
• Employee Stock Purchase Plan: Purchase Artivion stock at a discounted rate and share in our company's success
• Work-Life Balance: Benefit from a consistent and predictable work schedule
• Education Support: Tuition reimbursement to support your continued growth and development
• Employee Assistance Program (EAP): Access confidential resources for personal, financial, and emotional well-being
• Legal Benefits (LegalShield): Includes legal consultation, document review, will preparation, and 24/7 emergency access
• Financial Wellness: Access tools and resources through the Truist Momentum program
• Employee Discounts: Enjoy savings through Working Advantage, offering discounts on travel, entertainment, and more
• Efficient Hiring Process: We value your time and offer a streamlined interview process with timely feedback and decisions

Please Note: This is an onsite position reporting to our manufacturing facility in Austin, TX.