Quality Inspector II -Cleanroom, 1st Shift

Job Description:

POSITION SUMMARY

Performs inspection of critical components and completed assemblies used in Class III medical devices. Conducts visual and dimensional inspection of sub-assemblies or final system assemblies, during or post manufacturing processes. Interprets manufacturing procedures, drawings, and assembly inspection instructions in approving or rejecting in-process or final assemblies.

This role is for a first shift position, with standard working hours from 6:00am to 2:30pm.

RESPONSIBILITIES

This position is responsible for, but not limited to, the following:

Performs intermediate visual and dimensional inspection of product at in-process assembly and/or final inspection.

Approves finished products by confirming specifications, conducting visual and measurement tests, returning products for re-work

Reviews products for re-work and confirms conformity to required quality specifications

Ensures departmental compliance to all company policies relative to the manufacture of product, lot control requirements, documentation requirements, and safety (equipment, associate, and material).

Identifies and documents non-conformances to specifications.

Conducts batch record review and release, including review of NCMR’s, deviations etc.

Perform other TransMedics tasks and duties as assigned/required.

MANAGEMENT RESPONSIBILITIES

This position manages the following positions on a daily basis.

This position will not have management responsibilities.

PHYSICAL ATTRIBUTES

Ability to wear appropriate gowning attire for Clean Room environment (face covering, full length gown, hair covering, gloves, and other required PPE)

Ability to lift up to 40 pounds

Ability to stand for long periods of time