Quality Inspector I-Cleanroom, 1st Shift

Transmedics; Andover (MA); On-site; USD 34,000 - 43,000; Full time

Job summary

TransMedics, Inc. is seeking a Quality Inspector for second shift (2:30 PM – 11:00 PM) to inspect critical components and assemblies for Class III medical devices. You will perform visual and dimensional inspections, interpret procedures and drawings, and approve or reject in-process and final products.

This role emphasizes CGMP/GDP compliance, documentation, batch record review, and identification of non-conformances. Overtime and weekend work may be required.

Qualifications

• 1-3 years of Quality Control experience in medical device manufacturing.
• Must read and interpret drawings, procedures and blueprints.
• Proficient in basic measurement tools and math calculations.

Responsibilities

• Performs visual and dimensional inspection of in-process and final assemblies.
• Approves finished products by confirming specifications and conducting tests.
• Documents non-conformances and supports batch release reviews.
• Ensures compliance with CGMP/GDP and company policies.

Skills

Quality Control

Medical Device

CGMP

GDP

Inspection Tools

calculat

English Proficiency

Education

High School Diploma or equivalent

Tools

Vernier Calipers

Rulers

Microsoft Word

Microsoft Outlook

Job description

Job Description:POSITION SUMMARYPerforms 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 11:00PMRESPONSIBILITIESThis position is responsible for, but not limited to, the following: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-workReviews products for re-work and confirms conformity to required quality specificationsEnsures 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 RESPONSIBILITIESThis position manages the following positions on a daily basis.This position will not have management responsibilities.PHYSICAL ATTRIBUTESAbility 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 poundsAbility to stand for long periods of timeMINIMUM QUALIFICATIONS1-3 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 experienceUnderstanding of CGMP and GDP requiredIntermediate 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 QUALIFICATIONSPrior 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.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.comTransMedics 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 MADentalVisionHealthcare Flexible Spending AccountDependent Care Flexible Spending AccountShort Term DisabilityLong Term Disability401K PlanPet insuranceEmployee Stock Purchase PlanTransMedics 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.