Quality Inspector I Incoming, 1st Shift

TransMedics, Inc.•Andover, MA

4d•$25 - $32

About The Position

RESPONSIBILITIES This position is responsible for, but not limited to, the following: Under direct supervision, performs basic visual and dimensional inspection processes of components, equipment, and product labels at incoming, in process assembly and/or final inspection. Interprets route tickets, quality inspection documents and drawings and deciphers quality expectations for the product. Ensures compliance to all company policies relative to the manufacture of product, lot control requirements, documentation requirements, housekeeping. Performs and documents results of inspections per company procedures. Recognizes and communicates deviations from accepted practices Reports and generates material non-conformance reports (NCMR’s), enters data into Access database Perform other TransMedics tasks and duties as assigned/required. MANAGEMENT RESPONSIBILITIES This position manages the following positions on a daily basis. This position will not have management responsibilities. PHYSICAL ATTRIBUTES Ability to lift up to 40 pounds Ability to stand for long periods of time MINIMUM QUALIFICATIONS 1+ years of Medical Device Manufacturing or Quality experience Understanding of a quality management system (QMS), cGMP knowledge. Demonstrated ability to read and write English with ability to follow written instructions or procedures with minimal supervision. Must have legible writing, strong verbal and written communication skills. Must be able to measure products with rulers, calipers, gauges, or micrometers. Strong interpersonal skills and demonstrated positive attitude Strong work ethic and ability to manage time efficiently Ability to read, interpret, and understand drawings, blueprints and specifications Must be detail oriented and follow instructions and specifications meticulously. Must be able to accurately fill out paperwork as required. Must possess basic math skills: addition, subtraction, multiplication, division, weights and measures, and efficient use of a calculator Basic 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 Every Organ Wasted is a Life Not Saved. 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. www.TransMedics.com TransMedics is committed to equitable and transparent compensation. The expected hourly rate for this role is $24.71-$31.68, which represents the company’s current good-faith estimate of compensation for this position. Actual hour rate will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. Hourly roles may also be eligible for overtime, shift differentials, incentive programs, and our comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history. Employee Benefit: 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 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. Welcome to TransMedics Careers! Our Vision is to help save more patients' lives by becoming the trusted partner to transplant stakeholders worldwide and delivering the highest quality technology, service and clinical care. TransMedics Group, Inc. (TMDX) is a commercial-stage medical technology company transforming organ transplant therapy for end-stage organ failure patients across multiple disease states. We developed the Organ Care System, or the OCS™, to replace a decades-old standard of care that we believe is significantly limiting access to life-saving transplant therapy for hundreds of thousands of patients worldwide. Our innovative OCS technology replicates many aspects of the organ’s natural living and functioning environment outside of the human body. As such, the OCS represents a paradigm shift that transforms organ preservation for transplantation from a static state to a dynamic environment that enables new capabilities, including organ optimization and assessment. In concert with our OCS technology platform and OCS Connect™ app, which enables TransMedics and transplant clinicians to efficiently track, coordinate & communicate resource logistics for donor organs procured and maintained on OCS™, TMDX launched its National OCS™ Program (NOP) in 2022: 16 regional hubs across the U.S. staffed by a dispersed workforce of experienced, on-staff OCS Perfusion Specialists & Cardiothoracic and Abdominal Donor Procurement Surgeons. These resources are mobilized on-demand via our own dedicated ground & aviation transportation logistics network, to retrieve and deliver allocated donor organs from anywhere in the U.S. – aiding U.S. Transplant Centers in bidding farewell to the time & distance limitations of cold storage & expand the pool of viable donor organs for their transplant recipients.

Requirements

1+ years of Medical Device Manufacturing or Quality experience
Understanding of a quality management system (QMS), cGMP knowledge.
Demonstrated ability to read and write English with ability to follow written instructions or procedures with minimal supervision.
Must have legible writing, strong verbal and written communication skills.
Must be able to measure products with rulers, calipers, gauges, or micrometers.
Strong interpersonal skills and demonstrated positive attitude
Strong work ethic and ability to manage time efficiently
Ability to read, interpret, and understand drawings, blueprints and specifications
Must be detail oriented and follow instructions and specifications meticulously.
Must be able to accurately fill out paperwork as required.
Must possess basic math skills: addition, subtraction, multiplication, division, weights and measures, and efficient use of a calculator
Basic 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

Responsibilities

Performs basic visual and dimensional inspection processes of components, equipment, and product labels at incoming, in process assembly and/or final inspection.
Interprets route tickets, quality inspection documents and drawings and deciphers quality expectations for the product.
Ensures compliance to all company policies relative to the manufacture of product, lot control requirements, documentation requirements, housekeeping.
Performs and documents results of inspections per company procedures.
Recognizes and communicates deviations from accepted practices
Reports and generates material non-conformance reports (NCMR’s), enters data into Access database
Perform other TransMedics tasks and duties as assigned/required.