Quality Inspector I-Incoming Inspection, 1st Shift at TransMedics, Inc.

Andover, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

16 Aug, 26

Salary

35.17

Posted On

18 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Visual Inspection, Dimensional Inspection, Blueprint Reading, AQL Sampling, CGMP, GDP, Microsoft Word, Microsoft Outlook, Vernier Calipers, IPC-610, Medical Device Manufacturing, Quality Control

Industry

Medical Equipment Manufacturing

Description

Job Description: POSITION SUMMARY This position involves ensuring products meet established quality standards and specifications at various points in the organization. Duties include inspection of critical components and other raw goods and assemblies used in Class III medical devices, examining shipments of raw goods and electronic components, and inspecting required traceability documentation. Key responsibilities include visual and dimensional inspection, performing tests to determine product functionality, maintaining records, and collaborating with various teams to improve quality. This role is for a first shift position, with standard working hours from 7:00AM to 3:30PM. RESPONSIBILITIES This position is responsible for, but not limited to, the following: Perform intermediate visual and dimensional inspection of product at in-process assembly and/or final inspection. Interprets drawings, blueprints, and specifications to determine product acceptability. Approves products/batches by confirming specifications, and conducting visual and measurement tests. Select proper AQL samples based on batch sizes, where required. Record and reports inspection and testing data. Review and interprets supplier documentation, including certificates of analysis or conformance, packing slips, sterilization reports, and other lot traceability documentation. Monitor use of equipment to ensure it is calibrated before use; keeps measurement equipment operating accurately. Review products for re-work and confirms conformity to required quality specifications. Conduct visual inspection under magnification for printed circuit board assemblies (PCBA), confirming conformity to specifications and IPC standards as required. Ensure departmental compliance to all company policies relative to the manufacture of product, lot control requirements, documentation requirements, and safety (equipment, associate, and material). Identify and documents non-conformances to specifications. Conduct quality documents and lot traceability record review and release, including review of NCMR’s, deviations etc. 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 Ability to use microscopes or other magnification devices for long periods of time MINIMUM QUALIFICATIONS 1-3 years of Quality Control Experience in Medical Device Manufacturing Environments. High School Diploma or equivalent job experience with additional training in the trade; or equivalent combination of education and experience Understanding of CGMP and GDP required Intermediate computer knowledge required. Working knowledge of Microsoft Word, and Outlook required. Must be proficient in written and spoken English. Ability to read, interpret, and understand drawings, blueprints, and specifications. Must possess intermediate math skills: addition, subtraction, multiplication, division, and efficient use of a calculator. Knowledge of inspection tools such as rulers and vernier calipers required. Other inspection tools such as Tappi Charts, micrometers, height gauges, thread gauges, and Vision System knowledge a plus. PREFERRED QUALIFICATIONS Excellent verbal and written communication skills. Strong math skills including measuring dimensions using calibrated tools, and calculating specifications. IPC-610 Certification Knowledge of Microsoft Excel, Access, Powerpoint a plus. Ability to work overtime hours, or support weekend operations a plus. As part of our long-term growth plans, TransMedics is excited to announce our plan to relocate our headquarters (HQ) to Somerville, MA by 2028. We chose this location because we believe it is a place where innovation will thrive. Our new state-of-the-art headquarters is designed to support collaboration, creativity, and discovery. We believe this will be a place where we can continue to do things few thought possible in organ transplantation to help patients. Specific timing and role impact may vary. 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 $28.20-$35.17, 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.

Responsibilities

Perform visual and dimensional inspections of critical components and raw goods for Class III medical devices. Ensure product conformity by interpreting blueprints and maintaining detailed traceability documentation.