JOB OVERVIEW

The Quality Inspector is responsible in ensuring products and/or product components comply with specifications and quality standards. They test and inspect products at various stages of the production process against performance and customer integrity criteria to ensure product quality and reliability, and to determine the suitability of product release. Every team member is responsible for maintaining housekeeping and organization of the work area as well as following CathX Medical's EH&S policies and procedures. This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS).

ESSENTIAL FUNCTIONS:

• Interprets engineering drawings per ASME Y 5 and GD&T standards, interpret standard measurement units and their conversion formulas, record data from instruments to inspections sheets using Good Documentation Practices (GDP). Requires 100% guidance on daily activity.
• Select correct tools for measurement. Understand the ten times rule for measurement. Understand precision and accuracy measurement. Capable of using basic hand measurement tools (rules, calipers, snap gauges, micrometers, pin gauges, microscopes, drop gauges and timers).
• Selects products for tests at specified stages in production process, and tests products for attributes and/or variables requirements such as Visual, Dimensions, Performance, and Mechanical characteristics.
• Able to apply statistical quality control procedures such as inspection sampling plans (AQL, C=0, Z1.4, Z1.9).
• Capable of entering data into computer for

SUPERVISOR RESPONSIBILITIES:

This position does not have any supervisory responsibilities.

QUALIFICATIONS:

• ASQ Certified Quality Inspection certification or Mitutoyo Quality Inspector training certification or equivalent college, technical school or Company In-house Quality Inspector training certification.
• Knowledge of FDA 21 CFR, part 820 Quality System Regulations
• Knowledge of Good Manufacturing Process and Good Documentation Practice

COMPENTENCIES: To perform the job successfully, an individual should demonstrate the following competencies:

• Values: Integrity, Accountability, Teamwork, Innovation
• Excellent verbal and written communication skills
• Ability to work independently
• Ability to manage tight timelines and changing priorities
• Analytical and excellent problem-solving techniques
• Proficient with Microsoft office applications
• Generates creative solutions; demonstrates attention to detail

PHYSICAL DEMANDS AND WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

PHYSICAL DEMANDS:

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
• Visual Acuity - The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.

WORK ENVIRONMENT:

• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work). The performance of this position may occasionally require exposure to the manufacturing areas, which may require the use of personal protective equipment such as, gloves, frocks, hair and beard covers, face protection, foot protection, safety glasses with side shields and mandatory hearing protection.

TRAVEL:

This position does not require travel.

OTHER DUTIES:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.