Quality Inspector III-Cleanroom, 1st Shift

Job Description

POSITION SUMMARY

Quality Inspector III

Performs inspection of manufacturing goods during the manufacturing process. Conducts dimensional and electrical inspection of sub-assemblies or final systems assemblies. Interprets prints, manufacturing drawings, diagrams, wire cards and lists in approving or rejecting in-process or final assemblies.

Responsibilities

This position is responsible for, but not limited to, the following:

• Independently performs intermediate visual and dimensional inspection, testing and measurement of components, equipment and products at incoming, in process assembly and/or final inspection, including first article inspection
• Collects and compiles quality data and generates material nonconformance reports (NCMR’s) and enters in Access database.
• Conducts batch record review and release, including review of NCMR’s, deviations etc.,
• Interprets route tickets, quality inspection documents and drawings and deciphers quality expectations for the product.
• Approves finished products by confirming specifications, conducting visual and measurement tests, returning products for re-work
• Write detailed inspection reports (FAI) for parts, products and processes that fail inspection; investigates scope of failure and forwards report to engineering
• Compares measurements, form, fit, function, and value judgements of simple and complex parts to blueprint specifications and general workmanship standards using documents, experience, and knowledge of inspection techniques
• Monitors use of equipment to ensure it is calibrated before use; keeps measurement equipment operating accurately by following equipment requirements and calling for repairs when required.
• Ensures departmental compliance to all company policies relative to the manufacture of product, lot control requirements, documentation requirements, housekeeping, preventative maintenance, calibration, associate training, and safety (equipment, associate, and material)
• Assists in the development of test methods and inspection plans
• Trains new inspectors in all aspects of sterilization documentation review, DHR review, transaction processing and physical inspection of finished goods
• 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

• Clean Room environment
• Ability to lift up to 25 pounds
• Ability to stand for long periods of time
  
  

Minimum Qualifications

• 8 years of Quality Control experience in Medical Device Manufacturing. Knowledge of clean room operations a plus.
• High School Diploma or equivalent job experience with additional training in the trade; or equivalent combination of education and experience
  
  

Preferred Qualifications

• Excellent verbal and written communication skills.
• Strong math skills including data reporting, measuring, and calculating specifications
• Team oriented with outstanding interpersonal skills and positive attitude
• Ability to read, interpret, and understand drawings, blueprints, and specifications
• Intermediate computer knowledge.
  
  

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 first shift position, with standard working hours from 6am to 2:30pm.

• 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. The expected hourly rate for this role is $32.40-$41.59, 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 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.