Quality Inspector I-Cleanroom, 2nd Shift

Quality Control Inspector

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 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.

TransMedics 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 MADentalVision Healthcare Flexible Spending AccountDependent Care Flexible Spending AccountShort Term DisabilityLong Term Disability401K PlanPet 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.