Location: Andover,MA, USA
Job Description:
ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE:
* With minimal supervision, performs intermediate visual and dimensional inspection, testing and measurement of components, equipment, and product at incoming, 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 and deciphers quality expectations for the product.
* Selects proper AQL samples and reporting inspection and testing data.
* Approves finished products by confirming specifications, conducting visual and measurement tests, returning products for re-work and confirming re-work.
* Compares measurements, form, fit, and function of parts to blueprint specifications
* 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.
* Recognizes and proactively communicates verbal and written reports of conformances/non-conformances to specifications approving or rejecting raw materials with respect to quality standards and recording nonconformances in the quality database.
* Reports and generates material nonconformance reports (NCMR's) and enters into Access database.
* Ensures that all work assignments meet corporate quality and regulatory requirements
* Recommends activities to promote continuous improvement and best practices
* Performs other TransMedics tasks and duties as required
BACKGROUND AND QUALIFICATIONS:
* 3+ years 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
* Demonstrated 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, weights and measures, and efficient use of a calculator
* Ability to utilize AQL and process control where applicable
* Thorough knowledge of quality control standards and testing methodologies
* Knowledge of inspection tools such as rulers, calipers, gauges, or micrometers, height gauges, thread gauges and Comparator or Vision System.
* Team oriented with a demonstrated interpersonal skills and positive attitude
* Ability to independently manage time efficiently
* 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
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.