Quality Calibration Technician

About the Role

The Quality Calibration Technician ensures the compliance of the controlled equipment system, including calibration and day-to-day maintenance of equipment. This role involves reviewing calibration and preventative maintenance reports, entering calibration data, and scheduling routine calibration for new and existing equipment.

Responsibilities

• Maintain the electronic equipment scheduling database.
• Issue new equipment asset numbers and maintain history of calibration and PM events.
• Create and maintain calibration folders.
• Review, approve, and maintain calibration and preventative maintenance reports.
• Distribute calibration and PM schedules and past-due reports.
• Schedule external suppliers for offsite and onsite calibration and PM.
• Maintain proper identification and status of equipment.
• Perform other TransMedics tasks and duties as assigned or required.

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.

Requirements

• 1-3 years of experience in equipment calibration, calibration management, and/or calibration system software.
• Experience in controlled or cleanroom manufacturing environment and ESD controls.

Preferred Qualifications

• Strong math and basic statistical skills (mean, standard deviation, distributions).
• Familiarity with FDA Code of Federal Regulations (21 CFR Part 210, 211, or 820) and ISO 13485 knowledge.
• Strong computer skills (Microsoft Office, Access, MES, or other database software).
• Strong organizational skills and ability to handle multiple assignments simultaneously.
• Excellent interpersonal, written, and oral communication skills.
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.

About TransMedics

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 awaiting an organ transplant. We partner closely with transplant stakeholders worldwide to expand 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.

Benefits

• Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA.
• Dental and Vision coverage.
• Healthcare Flexible Spending Account.
• Dependent Care Flexible Spending Account.
• Short-Term and Long-Term Disability.
• 401K Plan.
• Pet insurance.
• Employee Stock Purchase Plan.