Contract Document Control & eQMS Coordinator

TransMedics, Inc.; Andover (MA); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Medical with Health Reimbursement Account

Dental

Vision

Short Term Disability

Long Term Disability

401K Plan

Pet insurance

Employee Stock Purchase Plan

Job summary

TransMedics, Inc. is seeking a Document Control Coordinator for a contract position to support the implementation of an electronic Quality Management System (eQMS). This role involves managing document lifecycle activities and ensuring compliance with regulatory requirements (FDA, ISO 13485, EU MDR) in a fast-paced medical device environment.

The ideal candidate will have 3-5 years of experience in documentation control, a High School Diploma, and proficiency in Microsoft Office. Benefits include medical, dental, vision insurance, and a 401K plan.

Qualifications

• 3 – 5 years’ experience in a Documentation Control role.
• Familiarity with eQMS platforms and document management systems.
• Working knowledge of FDA 21 CFR Part 820, Part 11, ISO 13485, and EU MDR requirements.

Responsibilities

• Assist in deploying and configuring the eQMS platform.
• Manage document lifecycle activities: creation, review, approval, and archival.
• Collaborate with teams to streamline documentation processes.

Skills

Detail-oriented

Interpersonal skills

Organizational skills

Attention to detail

Proficiency in Microsoft Office Suite

Education

High School Diploma

Tools

PDF editing tools

eQMS platforms

Job description

TransMedics, Inc. is seeking a Document Control Coordinator for a contract position to support the implementation of an electronic Quality Management System (eQMS). This role involves managing document lifecycle activities and ensuring compliance with regulatory requirements (FDA, ISO 13485, EU MDR) in a fast-paced medical device environment.

The ideal candidate will have 3-5 years of experience in documentation control, a High School Diploma, and proficiency in Microsoft Office. Benefits include medical, dental, vision insurance, and a 401K plan.