Cathx Quality Inspector - 1st Shift

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).

• Interprets engineering drawings per ASME Y 14.5 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 analysis.

• 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

Skills

• Good written and verbal communication skills
• Good Manufacturing Process and Good Documentation Practice
• Understands SOP's, MPI's, Procedures, Policies and Work Instructions
• Interprets engineering drawings per ASME Y 14.5 and GD&T standards and standard measurement units
• Select correct tools for measurement
• Capable of using basic hand tools (rulers, snap gauges, micrometer, pin gauge, microscope)
• Understands measurement methodology i.e. 10x rule for measurement, precision and accuracy
• Maintains detailed documentation and recording of data throughout inspection and testing
• Ability to write MRR's for failed units of inspection
• Clear understanding of FDA 21 CFR, part 820 Quality Systems Regulations
• ASQ Certified Quality Inspection or Certification/Mitutoyo Quality Inspector Training Certification
• Office 365 (Word, Excel & PowerPoint)
• 0 to 3 years’ experience

Competencies: 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

Salary Range - $28.00 - $34.00