QC Inspector II

TransMedics, Inc. • Andover, MA

84d

About The Position

This position is responsible for, but not limited to, the following: 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.

Requirements

• High School Diploma or equivalent job experience with additional training in the trade.
• 3+ years of Quality Control Experience in Medical Device Manufacturing.
• Knowledge of clean room operations.
• Understanding of a quality management system (QMS) and cGMP knowledge.
• Intermediate math skills: addition, subtraction, multiplication, division, weights and measures.
• Ability to read, interpret, and understand drawings, blueprints, and specifications.
• Detail oriented and follows instructions and specifications meticulously.
• 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 demonstrated interpersonal skills and positive attitude.
• Ability to independently manage time efficiently.

Responsibilities

• Perform intermediate visual and dimensional inspection, testing and measurement of components, equipment, and product.
• Conduct batch record review and release, including review of NCMR’s and deviations.
• Interpret route tickets and quality inspection documents.
• Select proper AQL samples and report inspection and testing data.
• Approve products by confirming specifications and conducting tests.
• Monitor use of equipment to ensure calibration before use.
• Ensure compliance with company policies related to product manufacture.
• Document results of inspections per company procedures.
• Recommend activities for continuous improvement and best practices.
• Perform other tasks and duties as assigned.

Benefits

• Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA
• Dental
• Vision
• Healthcare Flexible Spending Account
• Dependent Care Flexible Spending Account
• Short Term Disability
• Long Term Disability
• 401K Plan
• Pet insurance
• Employee Stock Purchase Plan

What This Job Offers

• Education Level: High school or GED
• Number of Employees: 501-1,000 employees