Quality Control Specialist

3 days ago

Andover, Massachusetts, United States TransMedics Full time
Job Title:

**Quality Control Specialist**

Job Summary:

We are seeking a highly skilled Quality Control Specialist to join our team at TransMedics. As a Quality Control Specialist, you will be responsible for ensuring the quality of our products by performing visual and dimensional inspections, testing, and measurement of components, equipment, and product at various stages of production.

Key Responsibilities:

  • Perform intermediate visual and dimensional inspections, testing, and measurement of components, equipment, and product at incoming, in-process assembly, and final inspection.
  • Conduct batch record review and release, including review of NCMRs, deviations, etc.
  • Interpret route tickets, quality inspection documents, and drawings to decipher quality expectations for the product.
  • Select proper AQL samples and report inspection and testing data.
  • Approve finished products by confirming specifications, conducting visual and measurement tests, returning products for re-work, and confirming re-work.
  • Compare measurements, form, fit, and function of parts to blueprint specifications.
  • Monitor use of equipment to ensure it is calibrated before use and keep measurement equipment operating accurately.
  • Ensure 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.
  • Perform and document results of inspections per company procedures.
  • Recognize and proactively communicate verbal and written reports of conformances/non-conformances to specifications, approving or rejecting raw materials with respect to quality standards, and recording non-conformances in the quality database.
  • Report and generate material nonconformance reports (NCMRs) and enter into Access database.
  • Ensure that all work assignments meet corporate quality and regulatory requirements.
  • Recommend activities to promote continuous improvement and best practices.
  • Perform other TransMedics tasks and duties as required.

Requirements:

  • 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.

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