QC Inspector II

TransMedics Group • Andover, MA

80d

About The Position

TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients' lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes. Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health. Maximize your potential at TransMedics, Inc.

Requirements

• High School Diploma or equivalent job experience with additional training in the trade; or equivalent combination of education and experience.
• 3+ year 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.
• Must possess intermediate math skills: addition, subtraction, multiplication, division, weights and measures, and efficient use of a calculator.
• 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.

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 a demonstrated interpersonal skills and positive attitude.
• Ability to independently manage time efficiently.

Responsibilities

• 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.

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

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