Quality Control Technician

Primary Responsibilities

• Performs visual and dimensional first piece of primary and secondary operations, in-process, final and first article inspection when needed.
• Proper and accurate utilization of measuring equipment: micrometers, calipers, optical comparator, height gage, indicators.
• Processes non-conforming material, reports data.
• Interprets engineering drawings/blueprints and confers with management or engineering departments to determine quality and reliability standards.
• Accurately enters data into EPICOR ERP.
• Ensures the required documentation is present and accurately fill out.
• Reviews job travelers and in process paperwork to ensure compliance and all criteria are met.
• May be responsible for calibrating, setting up, operating, and troubleshooting Coordinate Measuring Machine (CMM) machines. Should know how to do manual alignments.
• Assists team members with resolutions of any questions/issues that may arise before directing them to Quality MGMT.
• Must work responsibly with or without supervision using effective communication skills; able to collaborate with various departments and all levels of team members.
• Helps reduce scrap/waste, cost, time; drives for continuous improvement.
• Reliable, timely, ethical and consistent attendance.
• Other duties as assigned.

Qualifications

• High School Diploma or equivalent,
• or two to three years of experience, preferably in medical device manufacturing industry.
• or equivalent combination of education, training and/or experience.
• Knowledge of ISO 13485 Quality Management System & FDA 21CFR 820 Regulations is strongly preferred.
• Knowledge of Geometric Dimensioning and Tolerancing per ASME Y14.5M.
• Knowledge of reading and interpreting blueprints and schematics.
• Knowledge of CMM and computer aided inspection systems preferred (PC-DMIS, Keyence).

Language Ability

Ability to read, analyze, and interpret common scientific and technical manuals, training materials, financial reports, and legal documents (specifically in English). Ability to communicate effectively with tact, respect and professionalism within all levels of the organization.

Computer Skills

To perform this job successfully, an individual should have professional and working knowledge of Microsoft office and its applications (Excel), e-mail, communication platforms (Zoom, Teams). Knowledge of manufacturing software and ERP systems (EPICOR is strongly preferred). Knowledge of QCBD preferred.

Certificates and Licenses

No certifications required.

Managing Responsibilities

No direct reports.