Fitchburg, Massachusetts, USA
3 days ago
Quality Inspector

Summary: Seeking a meticulous Quality Inspector to perform daily inspections, assess non-conforming products, and ensure adherence to quality standards.

Job Requirements:

Experience as an inspector, preferably in the medical device industry

Proficient with inspection/test equipment such as CMM, Keyence Optical Measurement Systems, Micro Vu Video Measuring Machine, Optical Comparator (standard and eCAD), Micrometer, Calipers, Drop indicator, Pull-force tester, Hardness tester

High School Diploma or GED

Competent with Microsoft Office Programs

Familiarity with ISO 13485 standard and CFR 820 regulations

Understanding of Statistical Process Control principles

Preferred Skills:

CMM experience highly valued; may command a higher pay rate

Ability to read and interpret prints and customer requirements

Proficiency with standard dimensional gauges--caliper, micrometer, drop indicator, comparator

Job Responsibilities:

Perform daily inspections and communicate findings to Quality and area manager

Assess non-conforming product issues and initiate corrective/preventive actions

Update databases, logs, and reports with inspection results

Complete quality records accurately; maintain appropriate filing system

Coordinate Material Review Board (MRB) activities including segregation of nonconforming materials and logging information for consultation on disposition

Evaluate nonconforming materials for condition input

Conduct follow-up/effectiveness checks under Quality Engineers' guidance

Handle final product release activities

Support monitoring of quality/performance trends through data entry

Perform documentation review and dimension verification on received materials

Complete First Article Inspection as per Quality Engineering guidelines

Execute in-house calibrations of gauges following work instructions

Provide measurement support to validation activities

Verify products visually/dimensionally during in-process inspections

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