Quality Technician at TransMedics, Inc.

Andover, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

18 Jan, 26

Salary

0.0

Posted On

20 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Equipment Calibration, Calibration Management, Statistical Skills, Organizational Skills, Interpersonal Skills, Written Communication, Oral Communication, Self-Motivation, Adaptability, Positive Attitude, Cleanroom Manufacturing, ESD Controls, Database Software, Microsoft Office, FDA Regulations, ISO 13485

Industry

Medical Equipment Manufacturing

Description

Job Description: POSITION SUMMARY This position ensures the compliance of the controlled equipment system, both calibration and day to day maintenance of equipment. Duties include the review calibration and preventative maintenance reports, entering calibration data and schedule routine calibration of new and existing equipment. RESPONSIBILITIES This position is responsible for, but not limited to, the following: Maintain the electronic equipment scheduling database. Issue new equipment asset numbers and maintain history of calibration and PM events. Create and maintain calibration folders Review, approve and maintain calibration and preventative maintenance reports Distribute calibration and PM schedules and past due reports Schedule external suppliers for offsite and onsite calibration and PM Maintain proper identification and status of equipment Perform other TransMedics tasks and duties as assigned/required. PHYSICAL ATTRIBUTES Physical Activities: Mobility: Walking, standing, sitting, balancing, stooping, kneeling, crouching, reaching, pushing/pulling, lifting, carrying. Fine Motor Skills: Grasping, fine manipulation, feeling. Sensory Abilities: Vision: Close vision, distance vision, color vision, peripheral vision, depth perception, ability to adjust focus. Hearing: Ability to perceive sounds at normal speaking levels, including ability to hear and understand spoken instructions. Other Senses: Ability to perceive smells, tastes, or textures as relevant to the job. Environmental Factors: Temperature: Exposure to hot or cold environments. Noise: Exposure to loud or distracting noises. Hazards: Exposure to chemicals, machinery, or other potential dangers. Other Considerations: Repetitive Tasks: Frequency and duration of repetitive movements. Mental/Emotional Demands: Stress levels, ability to handle change (tasks, workload). Equipment Use: Ability to operate specific tools or machinery. Safety: Ability to work safely and follow safety procedures. MINIMUM QUALIFICATIONS 1-3 years experience in equipment calibration, calibration management and/or calibration system software Experience in controlled or cleanroom manufacturing environment and ESD controls Strong math and basic statistical skills (mean, std. dev., distributions) PREFERRED QUALIFICATIONS Familiarity with FDA Code of Federal Regulations (21 CFR Part 210, 211 or 820 preferred) and ISO 13485 knowledge preferred. Strong computer skills (Microsoft office, Access, MES or other database software) Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously. Excellent interpersonal skills, excellent written and oral communication skills. Ability to work independently and as part of a team, self-motivation, adaptability and a positive attitude. 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 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

The Quality Technician is responsible for ensuring compliance of the controlled equipment system, including calibration and maintenance of equipment. Duties include reviewing calibration reports, maintaining databases, and scheduling routine calibrations.