Job Description:

POSITION SUMMARY 

This is a Contract role

This position involves ensuring products meet established quality standards and specifications at various points in the organization.  Duties including examing shipments of raw goods, inspection of inprocess sub assemblies and accessories or final product.  Key responsibilities include inspection, testing and monitoring processes by identifying and addressing defects, maintaining records and collaborating with various teams to improve quality.

RESPONSIBILITIES 

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

• With minimal supervision, performs intermediate visual and dimensional inspection, testing and measurement of components, equipment, and product, in process assembly and/or final inspection. 
• Conducts batch record review and release, including review of NCMR’s, deviations etc.,
• Interprets route tickets, quality inspection documents and deciphers quality expectations for the product.
• Selects proper AQL samples and reporting inspection and testing data.
• Approves products by confirming specifications, conducting visual and measurement tests, returning products for re-work and confirming re-work
• Monitors use of equipment to ensure it is calibrated before use; keeps measurement equipment operating accurately
• 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)
• Performs and documents results of inspections per company procedures. 
• Ensures that all work assignments meet corporate quality and regulatory requirements
• Recommends activities to promote continuous improvement and best practices
• 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  

• Physical Activities:
  • Mobility: Walking, standing, sitting, balancing, stooping, kneeling, crouching, reaching, pushing/pulling, lifting, carrying. 
  • Fine Motor Skills: Grasping, fine manipulation, feeling. 

• Sensory Abilities:
  • Vision: Close vision, distance vision, color vision, peripheral vision, depth perception, ability to adjust focus. 
  • Hearing: Ability to perceive sounds at normal speaking levels, including ability to hear and understand spoken instructions. 
  • Other Senses: Ability to perceive smells, tastes, or textures as relevant to the job. 

• Environmental Factors:
  • Temperature: Exposure to hot or cold environments. 
  • Noise: Exposure to loud or distracting noises. 
  • Hazards: Exposure to chemicals, machinery, or other potential dangers. 

• Other Considerations:
  • Repetitive Tasks: Frequency and duration of repetitive movements. 
  • Mental/Emotional Demands: Stress levels, ability to handle change (tasks, workload).
  • Equipment Use: Ability to operate specific tools or machinery. 
  • Safety: Ability to work safely and follow safety procedures.        

MINIMUM QUALIFICATIONS 

• High School Diploma or equivalent job experience with additional training in the trade; or equivalent combination of education and experience
•  3+ year of Quality Control Experience in Medical Device Manufacturing.  Knowledge of clean room operations a plus
• Understanding of a quality management system (QMS) and cGMP knowledge
• Must possess intermediate math skills: addition, subtraction, multiplication, division, weights and measures, and efficient use of a calculator
• Ability to read, interpret, and understand drawings, blueprints, and specifications
• Detail oriented and follows instructions and specifications meticulously.
• Must be able to accurately fill out paperwork as required. 
• Intermediate computer knowledge.
• Flexible and able to work in a fast-paced, dynamic environment

PREFERRED QUALIFICATIONS

• Demonstrated ability to read and write English with ability to follow written instructions or procedures. Strong verbal and written communication skills.
• Knowledge of inspection tools such as rulers, calipers, or gauges
• Team oriented with a demonstrated interpersonal skills and positive attitude
• Ability to independently manage time efficiently

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.