Job Description:

ESSENTIAL TASKS AND DUTIES INCLUDE:

With minimal supervision, performs intermediate visual and dimensional inspection of product at 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 drawings to decipher quality requirements for the product.Reviews products for re-work and confirms conformity to required quality specificationsEnsures departmental compliance to all company policies relative to the manufacture of product, lot control requirements, documentation requirementsRecognizes and proactively communicates verbal and written reports of conformances/non-conformances to specifications.  Reports and generates material nonconformance reports (NCMR’s) and enters into Access database.Recommends activities to promote continuous improvement and best practicesPerforms other TransMedics tasks and duties as required

BACKGROUND AND QUALIFICATIONS:

3+ year of Quality Control Experience in Medical Device Manufacturing.  Knowledge of clean room operations a plusUnderstanding of cGMP  and GDP requiredDemonstrated ability to read and write English with ability to follow written instructions or procedures. Strong verbal and written communication skills.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 inspection tools such as Tappi Charts, micrometers, height gauges, thread gauges, and Vision System knowledge a plus.  Team oriented with demonstrated interpersonal skills and positive attitude Ability to independently manage time efficiently.Ability to read, interpret, and understand drawings and specifications.Detail oriented and follows instructions and specifications meticulously. Working knowledge of Miscrosoft Word, and Outlook required. Knowledge of Microsoft Excel, Access, Powerpoint a plus.

EDUCATION:

High School Diploma or equivalent job experience with additional training in the trade; or equivalent combination of education and experience

TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.