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.
• Safeguards required documentation and accurately fills out paperwork.
• 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.
• 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.
• 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.

Managing Responsibilities

• No direct reports.

Work Environment

• Office/Production Environment.
• This position has exposure to high-speed machinery and equipment and requires the use of safety glasses.
• The work environment of this position is generally performed in an indoor environment (at times in confined spaces) in a well-lit and ventilated area.
• There is exposure to machine oil, metal filings, and noise.
• Job functions on and around mechanized equipment will present the need for alertness, accuracy, and safety awareness.

Physical Demands

• The physical demands described must be met by an employee to successfully perform the essential functions of this job:
• The employee is required to regularly sit for long periods of time and occasionally to stand, walk, sit;
• use hands to finger, handle, or feel, talk and/or hear;
• reach with hands and arms.
• Ability to regularly lift and /or move up to 50 pounds.
• Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus.