Quality Control Specialist
3 days ago
Quality Control Specialist
Job Summary:
TransMedics is seeking a Quality Control Specialist to join our team. As a Quality Control Specialist, you will be responsible for performing intermediate visual and dimensional inspections, testing, and measurement of components, equipment, and products at incoming, in-process assembly, and/or final inspection.
Key Responsibilities:
- Conduct batch record reviews and releases, 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 the 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 (equipment, associate, and material).
- 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.
- 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.
- High School Diploma or equivalent job experience with additional training in the trade; or equivalent combination of education and experience.
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