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Quality Inspector

CathX Medical
San Jose, CA Full Time
POSTED ON 8/14/2024 CLOSED ON 10/18/2024

What are the responsibilities and job description for the Quality Inspector position at CathX Medical?

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 TE Connectivity'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.

Salary : $23 - $34

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