Quality Calibration Technician

Regulatory Jobs; Andover (MA); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Medical with Health Reimbursement

Dental

Vision

Healthcare Flexible Spending Account

Dependent Care Flexible Spending

Short Term Disability

Long Term Disability

401K Plan

Pet insurance

Employee Stock Purchase Plan

Job summary

TransMedics, Inc. in Andover, MA is seeking a Quality Calibration Technician to ensure compliant calibration and daily maintenance of our controlled equipment.

You will review calibration and preventive maintenance reports, enter calibration data, and schedule routine calibration for new and existing devices. You will maintain the electronic scheduling database, issue asset numbers, create calibration folders, coordinate with external suppliers for onsite/offsite calibration, and ensure accurate

Qualifications

• 1–3 years experience in equipment calibration and calibration management.
• Experience in controlled or cleanroom manufacturing environments and ESD controls.

Responsibilities

• Maintain electronic equipment scheduling database.
• Issue new equipment asset numbers and maintain calibration history.
• Review, approve and maintain calibration and preventive maintenance reports.
• Distribute calibration and PM schedules and overdue reports.
• Coordinate external suppliers for onsite and offsite calibration.

Skills

Calibration experience

Math & statistics

Communication skills

Organizational skills

Independent work

Tools

Microsoft Office

Access

MES / database software

Job description

Job Description:

POSITION SUMMARY

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

• 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.

MINIMUM QUALIFICATIONS

• 1-3 years 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, std. dev., distributions)
• Familiarity with FDA Code of Federal Regulations (21 CFR Part 210, 211 or 820 preferred) and ISO 13485 knowledge preferred.
• 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.

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

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.