Quality Inspector II-2nd Shift

TransMedics, Inc.•Andover, MA

3d•$30 - $30

About The Position

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 second shift position, with standard working hours from 2:30PM to 11:00PM.

Requirements

High School Diploma
3+ years of Quality Control Experience in Medical Device Manufacturing.
OR Equivalent job experience with additional training in the trade; or equivalent combination of education and experience
Understanding of a quality management system (QMS) and cGMP knowledge
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

Nice To Haves

Intermediate computer knowledge required.
Working knowledge of Microsoft Word, and Outlook required.
Must be proficient in written and spoken English.
Ability to read, interpret, and understand drawings, blueprints, and specifications.
Must possess intermediate math skills: addition, subtraction, multiplication, division, and efficient use of a calculator.
Knowledge of inspection tools such as rulers and vernier calipers required.
Other visual/cosmetic inspection tools such as Tappi Charts a plus.
Experience working in clean room environments.
Excellent verbal and written communication skills.
Strong math skills including measuring dimensions using calibrated tools, and calculating specifications.
Knowledge of Microsoft Excel, Access, Powerpoint a plus.
Ability to work overtime hours, or support weekend operations a plus.

Responsibilities

With minimal supervision, 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).
Recognizes and proactively communicates verbal and written reports of conformances/non-conformances to specifications.
Conducts batch record review and release, including review of NCMR’s, deviations etc.
Recommends activities to promote continuous improvement and best practices.
Perform other TransMedics tasks and duties as assigned/required.