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 ...
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 ...
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 ...
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 ...
Document Services Rep
Boston, MA · On-site
$19.95 - $23.10/hr
We are looking for a detail-oriented Document Services Rep to support document handling and administrative operations at an on-site office in Boston, Massachusetts. This Long-term Contract position ...
Quick apply
Document Services Rep
Boston, MA · On-site
$19.95 - $23.10/hr
We are looking for a detail-oriented Document Services Rep to support document handling and administrative operations at an on-site office in Boston, Massachusetts. This Long-term Contract position ...
Document Control Clerk
Westport, MA · On-site
$19.50 - $26.25/hr
Strong skills in Documentation and Document Management to create, organize, and maintain accurate records. * Experience in Records Management to ensure proper retention, archiving, and retrieval of ...
Document Control Clerk
Westport, MA · On-site
$19.50 - $26.25/hr
Strong skills in Documentation and Document Management to create, organize, and maintain accurate records. * Experience in Records Management to ensure proper retention, archiving, and retrieval of ...
Documentation Specialist
Worcester, MA · On-site
Established in 1991, Collabera is one of the fastest growing end-to-end information technology ... He/She will assign Change Request numbers for document and/or data changes. Preparation of ...
Documentation Specialist
Worcester, MA · On-site
Established in 1991, Collabera is one of the fastest growing end-to-end information technology ... He/She will assign Change Request numbers for document and/or data changes. Preparation of ...
Manager, Documentation
Wilmington, MA · On-site
$125 - $171.60/hr
Minimum 8 years in technical documentation, content strategy, or knowledge management within ... complex technical environments. * 2 years' experience leading a team, proven track record of ...
Manager, Documentation
Wilmington, MA · On-site
$125 - $171.60/hr
Minimum 8 years in technical documentation, content strategy, or knowledge management within ... complex technical environments. * 2 years' experience leading a team, proven track record of ...
Documentation Specialist
Andover, MA · On-site
Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in ... Review supplier documentation to support the creation of material supply channels and ensure supply ...
Documentation Specialist
Andover, MA · On-site
Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in ... Review supplier documentation to support the creation of material supply channels and ensure supply ...
We provide quality resources in four specialty areas: Information Technology (IT), Clinical ... Uploads/files/performs quality control on documents to be submitted to the Trial Master File.
We provide quality resources in four specialty areas: Information Technology (IT), Clinical ... Uploads/files/performs quality control on documents to be submitted to the Trial Master File.
Documentation Specialist-I
Boston, MA · On-site
Company Description Artech is the 10th Largest IT Staffing Company in the US, according to Staffing ... Tracking and reviewing change control documentation. Assist with the editing of quality documents ...
Documentation Specialist-I
Boston, MA · On-site
Company Description Artech is the 10th Largest IT Staffing Company in the US, according to Staffing ... Tracking and reviewing change control documentation. Assist with the editing of quality documents ...
Clinical Document Management Specialist
$39 - $52.50/hr
This is Contract position with my direct client Reporting to the Clinical Documentation Team Lead, and working in collaboration with the clinical study teams, the Clinical Document Management ...
Clinical Document Management Specialist
$39 - $52.50/hr
This is Contract position with my direct client Reporting to the Clinical Documentation Team Lead, and working in collaboration with the clinical study teams, the Clinical Document Management ...
Clinical Documentation Specialist
Lexington, MA · On-site
$39 - $52.50/hr
We provide quality resources in four specialty aretas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. * QC Review of pre-study and study documents. * Coding of ...
Clinical Documentation Specialist
Lexington, MA · On-site
$39 - $52.50/hr
We provide quality resources in four specialty aretas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. * QC Review of pre-study and study documents. * Coding of ...
Clinical Documentation Specialist
Concord, MA · On-site
$37 - $73/hr
In this role, you will help ensure the accuracy, completeness, and integrity of clinical documentation-supporting high-quality patient care, regulatory compliance, and appropriate reimbursement.
Clinical Documentation Specialist
Concord, MA · On-site
$37 - $73/hr
In this role, you will help ensure the accuracy, completeness, and integrity of clinical documentation-supporting high-quality patient care, regulatory compliance, and appropriate reimbursement.
Clinical Documentation Specialist
Lexington, MA · On-site
$39 - $52.50/hr
We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Title: Clinical Documentation Specialist Location: Lexington ...
Clinical Documentation Specialist
Lexington, MA · On-site
$39 - $52.50/hr
We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Title: Clinical Documentation Specialist Location: Lexington ...
Clinical Documentation Specialist
Lexington, MA · On-site
$39 - $52.50/hr
We provide quality resources in four specialty areas: Information Technology (IT), Clinical ... Client Direct Client Location Lexington, MA Job Title Clinical Documentation Specialist Duration ...
Clinical Documentation Specialist
Lexington, MA · On-site
$39 - $52.50/hr
We provide quality resources in four specialty areas: Information Technology (IT), Clinical ... Client Direct Client Location Lexington, MA Job Title Clinical Documentation Specialist Duration ...
Clinical Document Management Specialist
$39 - $52.50/hr
Reporting to the Clinical Documentation Team Lead, and working in collaboration with the clinical study teams, the Clinical Document Management Specialist (CDMS) is responsible for the management and ...
Clinical Document Management Specialist
$39 - $52.50/hr
Reporting to the Clinical Documentation Team Lead, and working in collaboration with the clinical study teams, the Clinical Document Management Specialist (CDMS) is responsible for the management and ...
Clinical Document Management Specialist
$39 - $52.50/hr
Reporting to the Clinical Documentation Team Lead, and working in collaboration with the clinical study teams, the Clinical Document Management Specialist (CDMS) is responsible for the management and ...
Clinical Document Management Specialist
$39 - $52.50/hr
Reporting to the Clinical Documentation Team Lead, and working in collaboration with the clinical study teams, the Clinical Document Management Specialist (CDMS) is responsible for the management and ...
Manager, Documentation
Wilmington, MA · Hybrid
In this role, you will build and govern a structured knowledge layer that deeply integrates with training, technical support, and product delivery, ensuring our documentation is optimized for ...
Manager, Documentation
Wilmington, MA · Hybrid
In this role, you will build and govern a structured knowledge layer that deeply integrates with training, technical support, and product delivery, ensuring our documentation is optimized for ...
Packaging Documentation Specialist - MDI
Fall River, MA · On-site
$66K - $86K/yr
In this role the Documentation Specialist adheres to the company's document and SOP's procedures while ensuring their accuracy, quality, and integrity. This position reports to the Site Lead ...
Packaging Documentation Specialist - MDI
Fall River, MA · On-site
$66K - $86K/yr
In this role the Documentation Specialist adheres to the company's document and SOP's procedures while ensuring their accuracy, quality, and integrity. This position reports to the Site Lead ...
$66K - $86K/yr
In this role the Documentation Specialist adheres to the company's document and SOP's procedures while ensuring their accuracy, quality, and integrity. This position reports to the Site Lead ...
$66K - $86K/yr
In this role the Documentation Specialist adheres to the company's document and SOP's procedures while ensuring their accuracy, quality, and integrity. This position reports to the Site Lead ...
AdaptHealth is a premier full-service home medical equipment company in the United States ... Documentation Specialistscreateand generateselectronic forms requesting patient documentsfrom ...
AdaptHealth is a premier full-service home medical equipment company in the United States ... Documentation Specialistscreateand generateselectronic forms requesting patient documentsfrom ...
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Full-time
Medical, Dental, Vision, Retirement
Re-posted 7 days ago
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.
About Transmedics
Sourced by ZipRecruiter
Industry
Medical equipment and supplies manufacturing
Company size
501 - 1,000 Employees
Headquarters location
Andover, MA, US
Year founded
1998