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Quality Specialist

1 month ago

Kanata, Canada Genomadix Full time

The Quality Specialist will be responsible for supporting all aspects of Genomadix Electronic Documentation Management Systems (EDMS), and Quality Systems. Self-motivated and software savvy, the Quality Specialist will have the ability to work with multiple departments to support the quality systems, quality documentation and training requirements of Genomadix.

**What you’ll be doing**:

- Work to update and transition all EDMS items to the desired document type aligned with the quality systems moving forward as Genomadix.
- Support the transition from the old documentation templates to the new Genomadix templates for EDS items
- Manage Document control inputs, including change requests (CR’s)
- Assist with linking documents, and coaching department SMEs in the parent/child concept within the EDMS.
- Support training program in EDMS, and roll out training for new procedures, new hires and new roles as required
- Establish and track metrics related to training for each department
- Provide oversight and support for Investigations and CAPA
- Help manage Approved Suppliers List and Supplier Qualification Program
- Supporting the organization in other tasks as required

**What you bring to the table**:

- Bachelor's degree (or higher) in a relevant discipline or equivalent experience
- Knowledge of Quality Systems (Health Canada Medical Device regulations, ISO 13485 and/or US CFR 820 (FDA) preferred
- Experience in EDMS is preferred, and extensive knowledge of Good Documentation Practices and Change Control is required
- Understanding of quality systems, including investigations, Corrective Action/Preventative Action and Supplier Qualifications is preferred
- Superuser in Microsoft Office (Word, Excel, PowerPoint) and Adobe Acrobat
- Strong attention to detail with the ability to multitask and handle fluctuating workloads simultaneously.
- Effective communication skills and a team player willing to work with everyone to accomplish tasks
- Genomadix Inc. is an equal opportunity employer and is committed to an inclusive, barrier-free recruitment and selection processes and work environments. Please let us know of any accommodations needed to ensure you have access to a fair and equitable process._

**Job Types**: Full-time, Permanent

**Salary**: $55,000.00-$65,000.00 per year

**Benefits**:

- Casual dress
- Company events
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Life insurance
- On-site gym
- On-site parking
- Paid time off
- Vision care

Flexible Language Requirement:

- French not required

Schedule:

- Monday to Friday

Work Location: One location

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