Top 27038 Documentation coordinator Jobs

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- Employee stock purchase plan
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1d

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Documentation Control Coordinator (Contract)

TransMedics, Inc. -
Andover, MA

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Job Details

Full-time

Benefits

Employee stock purchase plan
Disability insurance
Dental insurance
401(k)
Flexible spending account
Vision insurance
Pet insurance

Qualifications

ISO standards
Regulatory compliance
FDA 21 CFR Part 11
High school diploma or GED
Biomedical regulatory compliance
Document viewing software
Productivity software
Editing

Full Job Description

Job Description:

This role is contract position. TransMedics is seeking a detailed oriented Document Control Coordinator to support the implementation of an electronic Quality Management System (eQMS) and assisting with Document Control Department support in a fast-paced medical device environment. This role is critical to ensuring compliance with regulatory requirements (FDA, ISO 13485, EU MDR) and maintaining robust documentation practices throughout the organization.

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

Assist in the deployment and configuration of the eQMS platform
Manage document lifecycle activities: creation, review, approval, distribution, revision, and archival
Ensure documents meet internal formatting standards and regulatory requirements
Maintain accurate records of controlled documents and change history
Monitor compliance with document control policies and escalate discrepancies
Collaborate with Quality, Regulatory, R&D, and Operations teams to streamline documentation processes
Internal reporting for various company system metricsthe goal
Scanning of Quality Documentation
Help to maintain training records within the document management system
Perform other TransMedics job-related tasks and duties, as assigned

MANAGEMENT RESPONSIBILITIES

This position manages the following positions on a daily basis.

This position will not have management responsibilities.

PHYSICAL ATTRIBUTES

Office environment
Must be able to lift up to 30lbs

MINIMUM QUALIFICATIONS

Minimum of 3 - 5 years’ experience in Documentation Control role.
High School Diploma
Familiarity with eQMS platforms and document management systems
Working knowledge of FDA 21 CFR Part 820, Part 11, ISO 13485, and EU MDR Requirements
Strong attention to detail and organizational skills
Excellent communication and interpersonal abilities
Proficiency in Microsoft Office Suite and PDF editing tools

PREFERRED QUALIFICATIONS

Medical Device experience preferred.
Experience with eQMS implementation or migration projects
Some knowledge of validation and change control processes
Ability to manage multiple priorities in a regulated environment

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.

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.

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Refine Your Search

documentation coordinator jobs

Documentation Control Coordinator (Contract)

Coordinator, Quality Documentation

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Document review Coordinator

Administrative Coordinator

Patient Care Coordinator

Patient Care Coordinator (Remote)

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Part-Time Care Coordinator (Flexible Hours)

Relief Referral Coordinator

Care Management Support Coordinator

Care Coordinator Bilingual ( English& Spanish)

Liens and Legal - Lien Coordinator

Case Coordinator I

Data Management Coordinator

Medical Education Coordinator

Patient Care Coordinator (Remote)

Intake Coordinator (Remote)

Patient Benefits Coordinator

Licensing Coordinator

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