Quality Specialist

Job Title: Quality Specialist

Department: QA

Job Description:

The Quality Specialist will be responsible for supporting all aspects of Genomadix Quality Management System. Specific focus will be on the EDMS (Electronic Documentation Management System). Within Ensur (the current EDMS) the Quality Specialist will have sole responsibility of the training platform for the company.

Self-motivated and software savvy, the Quality Specialist will have the ability to work with multiple departments to support the quality documentation and training requirements of Genomadix.

What youll be doing:

• Work to update and transition all documentation within the EDMS, to current Genomadix formatting, while supporting the archival of documentation no longer relevant to products on the market.
• Manage Document control inputs, including change orders (COs). Review and support all departments in the change control quality system. Act as SME For Change Orders (CO) and ensure all documentation is attached for CO reviews, work with department SMEs to answer questions and provide guidance related to CO. Coordinate CRB (Change Review Board meetings).
• Support training program in EDS, and roll out training for new procedures, new hires and new roles as required.
• Communicate with area leaders as training in their departments requires attention.
• Track metrics for QMS (quality management system) and hold routine QMR (Quality Metrics Review) meetings.
• Assist with CAPA completion and CAPA effectiveness checks.
• Other duties to support the Quality Management System at Genomadix as required.

What you bring to the table:

• Post Secondary education in Science preferred OR equivalent experience.
• Knowledge of Quality Systems (Health Canada Medical Device regulations, ISO 13485 and/or US CFR 820 (FDA) preferred.
• Experience in Electronic Documentation Systems (EDS) is preferred.
• Understanding of change control process within a quality system is required.
• Superuser in Microsoft Office (Word, Excel, PowerPoint) and Adobe Acrobat
• Strong attention to detail with the ability to multitask and handle fluctuating workloads simultaneously.
• Good communication skills and be a team player willing to work with everyone to accomplish tasks.