Quality Calibration Technician (Contract)

TransMedics, Inc.•Andover, MA

About The Position

POSITION SUMMARY This is a contract position. The Quality Calibration Technician ensures the compliance of the controlled equipment system, both calibration and day to day maintenance of equipment. Duties include the review calibration and preventative maintenance reports, entering calibration data and schedule routine calibration of new and existing equipment. RESPONSIBILITIES This position is responsible for, but not limited to, the following: 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/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.

Requirements

Familiarity with FDA Code of Federal Regulations (21 CFR Part 210, 211 or 820 preferred) and ISO 13485 knowledge preferred.
Experience in controlled or cleanroom manufacturing environment and ESD controls
Strong math and basic statistical skills (mean, std. dev., distributions)

Nice To Haves

1-3+ years experience in equipment calibration, calibration management and/or calibration system software
Strong computer skills (Microsoft office, Access, MES or other database software)
Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously.
Excellent interpersonal skills, excellent written and oral communication skills.
Ability to work independently and as part of a team, self-motivation, adaptability and a positive attitude.

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/required.