Document Control Specialist

About the job

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 INCLUDE:

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.

Apply Via LinkedIn