Quality Inspector II -Cleanroom, 1st Shift

Transmedics; Andover (MA); On-site; USD 37,195 - 48,216; Full time

Benefits offered by this job

Medical benefits

Dental

Vision

401K Plan

Paid time off

Employee stock plan

Job summary

TransMedics is seeking a Quality Inspector to perform inspection of critical components and assemblies for Class III medical devices. The role includes visual and dimensional checks, line-side approvals, and documentation of non-conformances.

The position is first shift (6:00am–2:30pm) in a clean-room environment, requiring gowning and the ability to lift up to 40 pounds. Strong English skills and basic math are essential.

Qualifications

• 1-3 years of Quality Control Experience in Medical Device Manufacturing.
• High School Diploma or equivalent with additional training; or equivalent experience.
• Understanding of CGMP and GDP required; proficient in basic math and measurements.

Responsibilities

• Performs intermediate visual and dimensional inspection of product at in-process or final inspection.
• Approves finished products by confirming specifications via visual and measurement tests.
• Reviews products for re-work and confirms conformity to quality specs; documents non-conformances.

Skills

Quality control

Visual inspection

Dimensional measurement

CGMP/GDP knowledge

MS Word/Outlook

Education

High School Diploma

Tools

Rulers

Vernier calipers

Tappi charts

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 first shift position, with standard working hours from 6am to 2:30pm.RESPONSIBILITIESThis 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.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 $27.55-$35.34, 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.