Quality Inspector I-Cleanroom, 1st Shift

TransMedics, Inc.; Andover (MA); On-site; USD 33,000 - 44,000; Full time

Job summary

TransMedics, Inc. is seeking a Quality Control Inspector for the second shift to perform visual and dimensional inspection of components and assemblies used in Class III medical devices.

The role requires reading procedures, drawings, and inspection instructions to approve or reject in-process or final products.

Qualifications

• High School Diploma or equivalent with trade training.
• Understanding of CGMP and GDP.
• Intermediate computer skills including Word and Outlook.
• Ability to read and interpret drawings and specifications.
• Experience with measurement tools such as rulers and calipers.

Responsibilities

• Performs intermediate visual and dimensional inspection of product at in-process assembly and/or final inspection.
• Approves finished products by confirming specifications, conducting visual and measurement tests, returning products for re-work.
• Reviews products for re-work and confirms conformity to required quality specifications.
• Ensures departmental compliance to all company policies relative to the manufacture of product, lot control requirements, documentation requirements, and safety (equipment, associate, and material).
• Identifies and documents non-conformances to specifications.
• Conducts batch record review and release, including review of NCMR’s, deviations etc.
• Perform other TransMedics tasks and duties as assigned/required.

Skills

CGMP knowledge

GDP knowledge

MS Word

Outlook

Blueprint reading

Reading drawings

Math skills

Caliper measurement

Ruler measurement

Tappi Charts

English proficiency

Education

High School Diploma or equivalent with trade training

Tools

Microsoft Excel

PowerPoint

Rulers

Vernier calipers

Job description

Job Description

Position Summary: Performs inspection of critical components and completed assemblies used in Class III medical devices. Conducts visual and dimensional inspection of sub-assemblies or final system assemblies, during or post manufacturing processes. Interprets manufacturing procedures, drawings, and assembly inspection instructions in approving or rejecting in-process or final assemblies. This role is for a second shift position, with standard working hours from 2:30PM to 11:00PM.

Responsibilities

• Performs intermediate visual and dimensional inspection of product at in-process assembly and/or final inspection.
• Approves finished products by confirming specifications, conducting visual and measurement tests, returning products for re-work.
• Reviews products for re-work and confirms conformity to required quality specifications.
• Ensures departmental compliance to all company policies relative to the manufacture of product, lot control requirements, documentation requirements, and safety (equipment, associate, and material).
• Identifies and documents non-conformances to specifications.
• Conducts batch 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 wear appropriate gowning attire for Clean Room environment (face covering, full length gown, hair covering, gloves, and other required PPE)
• Ability to lift up to 40 pounds
• Ability to stand for long periods of time

Minimum Qualifications

• 1-3 years of Quality Control Experience in Medical Device Manufacturing.
• 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 visual/cosmetic inspection tools such as Tappi Charts a plus.

Preferred Qualifications

• Prior experience working in clean room environments.
• Excellent verbal and written communication skills.
• Strong math skills including measuring dimensions using calibrated tools, and calculating specifications.
• Knowledge of Microsoft Excel, Access, Powerpoint a plus.
• Ability to work overtime hours, or support weekend operations a plus.

Company Information and Mission

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.

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 hourly 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.

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

Equal Opportunity and Diversity Statement

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.

Other Company Highlights

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.