Document Control Specialist

Trudell Medical International; London; On-site; CAD 50,000 - 65,000; Full time

Job summary

A regulated medical device company is seeking a Document Control Administrator to ensure efficient processing, maintenance, and distribution of controlled documents. The ideal candidate will have a diploma in administration, experience in an office setting, and strong skills in document control and administration. Proficiency in MS Office and familiarity with quality management systems are essential for success in this role.

Qualifications

• 2 years of experience in an office setting, preferably in a manufacturing environment.
• Experience in document control or administrative roles in an engineering or quality management systems environment is an asset.
• Basic knowledge of ISO 13485 compliant quality programs.

Responsibilities

• Maintain records control process for a medical device manufacturing company.
• Track and perform quality checks on electronic documentation.
• Assist departments in creation and processing of quality management system documentation.

Skills

Organizational skills

Interpersonal skills

Document control

Administration

Education

Diploma in Administration or related field

Tools

MS Office

MasterControl

Adobe

MS Dynamics Great Plains

SolidWorks

MS Project

BarTender

Job description

Overview

Drive the efficient and compliant processing, maintenance, distribution, and storage of documents controlled under TMI’s Quality Management System. Drive process improvements and effectiveness and act as MasterControl system Sub-Admin.

Responsibilities

• Document Control
  • Maintain the records control process of a highly regulated, medical device manufacturing company
  • Track, maintain, and perform quality check of electronic documentation
  • Maintains up to date DHF/DMR Index as required
  • Coordinate and control Design History File documents outside of MasterControl
  • Assist Science & Technology, Quality, Purchasing and Manufacturing in the creation and processing of QMS documentation necessary to define product configurations, control manufacturing processes, and engineering changes
  • Maintain centralized standards library
• MasterControl Sub-Admin
  • Provide support to users when they encounter difficulties
  • Escalate “unsolvable” technical issues and communicate process improvements to Sysadmin
  • Assign appropriate roles/ rights to users
  • Oversee receipt, completeness, and quality of production records and maintain a highly organized records flow.
  • Schedule and run reports as required
  • Interact with the required departments to route change control documentation to ensure adequate approval
• Change Control
  • Administer, review, track and manage change requests Drive effectiveness and efficiencies
• Bill of Materials (BoM)
  • Create item masters, initiate item master sheet, and coordinate the information gathering
  • Circulate draft of BoM, monitor changes, and release final BoM in ERP system (Great Plains)
• Document Services
  • Back-up Document Services activities:
  • Preparation, submission, and tracing regulatory documentation to support international product registrations
  • Maintain confidentiality requirements
  • Assist in gathering information for pending regulatory submissions
• Health and Safety
  • Ensure compliance with relevant health and safety legislation, including the Workplace Safety and Insurance Act, the Occupational Health and Safety Act, etc.

Qualifications

• Diploma in Administration or a related field of study
• 2 years of experience in office setting, preferably in a manufacturing environment, or relevant education
• Experience in document control or equivalent administrative experience in an engineering, manufacturing or quality management systems environment is an asset
• Computer literate with:
• Advanced experience in a Windows environment
• Advanced experience in MS Office applications
• Advanced experience in Adobe
• Basic to intermediate experience in MS Dynamics Great Plains is an asset
• Intermediate experience in MasterControl is an asset
• Basic knowledge of bar code label software dashboard, e.g. BarTender
• Basic to intermediate experience in MS Project is an asset
• Basic experience in SolidWorks is an asset
• Working knowledge of the requirements of an ISO 13485 compliant quality program is an asset
• Strong organizational and general administrative skills
• Good interpersonal skills with the ability to work independently

At an applicant’s request, TMI will make accommodation to its recruitment process to meet the needs of applicants with disabilities.