QC Inspector II (Contract)

TransMedics•Andover, MA

About The Position

POSITION SUMMARY This is a Contract role This position involves ensuring products meet established quality standards and specifications at various points in the organization. Duties including examing shipments of raw goods, inspection of inprocess sub assemblies and accessories or final product. Key responsibilities include inspection, testing and monitoring processes by identifying and addressing defects, maintaining records and collaborating with various teams to improve quality.

Requirements

High School Diploma or equivalent job experience with additional training in the trade; or equivalent combination of education and experience
3+ year of Quality Control Experience in Medical Device Manufacturing.
Knowledge of clean room operations a plus
Understanding of a quality management system (QMS) and cGMP knowledge
Must possess intermediate math skills: addition, subtraction, multiplication, division, weights and measures, and efficient use of a calculator
Ability to read, interpret, and understand drawings, blueprints, and specifications
Detail oriented and follows instructions and specifications meticulously.
Must be able to accurately fill out paperwork as required.
Intermediate computer knowledge.
Flexible and able to work in a fast-paced, dynamic environment

Nice To Haves

Demonstrated ability to read and write English with ability to follow written instructions or procedures.
Strong verbal and written communication skills.
Knowledge of inspection tools such as rulers, calipers, or gauges
Team oriented with a demonstrated interpersonal skills and positive attitude
Ability to independently manage time efficiently

Responsibilities

With minimal supervision, performs intermediate visual and dimensional inspection, testing and measurement of components, equipment, and product, in process assembly and/or final inspection.
Conducts batch record review and release, including review of NCMR’s, deviations etc.,
Interprets route tickets, quality inspection documents and deciphers quality expectations for the product.
Selects proper AQL samples and reporting inspection and testing data.
Approves products by confirming specifications, conducting visual and measurement tests, returning products for re-work and confirming re-work
Monitors use of equipment to ensure it is calibrated before use; keeps measurement equipment operating accurately
Ensures departmental compliance to all company policies relative to the manufacture of product, lot control requirements, documentation requirements, housekeeping, preventative maintenance, calibration, associate training, and safety (equipment, associate, and material)
Performs and documents results of inspections per company procedures.
Ensures that all work assignments meet corporate quality and regulatory requirements
Recommends activities to promote continuous improvement and best practices
Perform other TransMedics tasks and duties as assigned/required.