Document Control Associate

2 weeks ago

Barrie, Canada Southmedic Inc. Full time

The Document Control Associate is responsible for the administration and maintenance of the Quality Policy Manual and all other Quality System controlled documents. The position provides support with the daily maintenance of the Training Program at Southmedic Inc. and with labelling in order to meet the time sensitive needs of internal and external customers.

**KEY DUTIES**
- Management of the Quality Policy Manual and electronically controlled document revisions, updates, and changes within uniPoint.
- Manage current revisions of externally controlled documents.
- Serve as a uniPoint administrator.
- Facilitate all changes to QMS Document within uniPoint.
- Document revisions, updates and changes associated with Engineering Change Notices (ECN’s)
- Support the creation of all in-house labels, IFU’s, and related documents.
- Support graphic file updates for labels and IFU’s printed externally.
- Shall be familiar with the Southmedic Quality System and follow the ISO 13485:2016, MDR and MDSAP requirements.
- Responsible for the tracking and storage of all quality related and job-specific training documentation and the administration of the training module uniPoint.
- Responsible in conjunction with the Process Owner/Author for the decision on the training method and the employees requiring training following the release of a new and/or revised document.
- Aid department managers in the creation of training plans related to job descriptions/responsibilities.
- Provide updated training reports to support production, document change process and management requests.
- Facilitate internal and 3rd party training as required.
- Participate within corrective action teams as required.
- Take ownership of projects and work independently within a team environment to reach departmental and company goals.
- Support a variety of projects as required.

**DIMENSIONS OF THE POSITION**
- Experience working within a Quality Management System within a regulated manufacturing environment or industry.
- Experience working within an electronic document software.
- Strong technical writing and verbal communication skills
- Attention to detail and seasoned interpersonal skills
- Strong organizational skills, ability to manage multiple priorities in a fast-paced environment.
- Conflict resolution skills
- Self-motivated and goal oriented
- Ability to work both in a team setting, and independently with mínimal supervision.
- Excellent time management skills with the ability to meet tight deadlines
- Experience in taking ownership of projects
- Must be comfortable as a liaison between multiple departments
- Flexible to work all shifts and overtime with mínimal notice.
- Communicating effectively and professionally with customers, suppliers, registrars, regulatory authorities and with fellow Southmedic employees
- Maintain strict confidentiality with respect to pending documentation revision changes that could have an impact to current employees. This includes changes to the Organizational Chart as well as changes to policies and procedures.

**The following would be considered an asset**:

- Post-secondary education in Quality Assurance, Business Administration, Medical Administration, or a science-based discipline, and/or a minimum of 2 years’ experience in a Quality Assurance role
- Familiarity with GMPs, MDR, CE, MDSAP, and FDA Part 820 requirements
- Demonstrated technical writing ability
- Experience in root cause analysis, decision making, data analysis, customer service, meeting management.
- Previous experience in internal auditing and or a member of Southmedic’s Internal Audit Team

Southmedic is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). If you require accommodation for disability during any stage of the recruitment process, please advise the Human Resources Department.

SM

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