Quality Assurance Specialist

Cardinal Health Canada, with over 1300 employees nationwide, is an essential link in the Canadian healthcare supply chain, providing over 70,000 products to healthcare facilities and medical professionals across the country.

Cardinal Health-Gananoque manufactures many life-impacting medical devices that help our customers thrive in a changing world. We are your humble partners, striving each day to make healthcare more efficient and effective and our patients as healthy as possible. We are more than 450 employees with 119 years of Canadian history, a deep understanding of the medical devices we manufacture every day and a passion for innovation.

**Your Contributions to the Organization will be**:
Responsible for seeing that all tasks are performed in a manner that complies with internal policies, corporate governance as well as ISO and FDA requirements.

CDP Change Analyst - Change Control:

- Facilitate the management of CDP projects and statuses ensuring all appropriate information is added as required (attributes, affected items, attachments, etc.)
- Review CDP Plans to ensure all deliverables are identified; route for Review Planning approvals (per corporate approval matrix)
- Ensure that all deliverables identified in the Plan-Summary and Implementation worksheets are Related/Attached to support the objective evidence
- Ensure Change Orders are at the appropriate status and on the Relationships tab and attachments are attached to CDP; route for Review Evaluation approvals per corporate approval matrix.
- Support Project Leaders on initiating, submitting CDP’s; assist with completion of Quality Plans and Quality Plan Checklists.
- Attend CDP/QP review meetings (internal and external).

Site Change Analyst - Document/Part Control:

- Review facility change orders in Agile for document and part object changes and additions, add the appropriate approvers to each change order per corporate approval matrix and route for approvals.
- Make change orders effective in Agile once fully approved.
- Create new raw material and subassembly part objects in Agile.
- Revise bill of materials (including usage and scrap levels) in Agile.

Agile Site Subject Matter Expert:

- Conduct Agile training for all new hires as required and request Agile access for all site employees.
- Act as the ‘go to person’ for any Agile questions/issues.
- Attend conference call meetings with the Technical Documents Group (Mansfield) and all facility Change Analysts.
- Work with Technical Documents Group (Mansfield) on any Agile questions/issues or product absolutions.

Quality System Document Control:

- Revise facility level procedures (General, Process and Lab SPI's) and Formula Sheets in Agile and internal quality system forms (internal process).
- Maintain the (QSMDL) Quality System Master Document List access database.
- Maintain electronic and hard copy files of documents and changes as applicable. File all hard copy Document Change Requests (DCR’s) and Document Change Notices (DCN’s).
- Ensure that issued hard copies of documents are adequately controlled through use of QSMDL.
- Print, copy, scan, upload pdf’s and distribute (hard copy or electronically) all documentation changes as per QSMDL distribution.
- Support Quality staff/all departments on document change/control questions; assisting them on finding procedures and forms; assisting with DCR and Change Order submissions.

MyLearning Administrator (Online Learning System):

- Assign quality system revision updates, add new quality system procedures and other assignments/training as required in MyLearning.
- Maintenance of user groups/curriculums for quality system documents.
- Assist employees with locked assignments as required.
- Add historical completions as required.
- Create and run reports in MyLearning as required.

BPCS LX Maintenance:

- Correct any issues that may arise from errors when change orders are released from Agile into BPCS.
- Maintain records for raw materials, subassemblies and finished goods in BPCS (fields that do not feed from Agile).

Auditing:

- Conduct quality system internal audits.
- Support internal and external quality system audits and participate in external audits.

Continuous Improvement Initiatives:

- Support Quality Improvement Initiatives (QIP) continuous improvement initiatives.
- Support Quality Begins with Me (QBWM) initiatives.

Other:

- Coordinate and order supplies for the quality department, ensuring that spending is within QA budget.
- Support EHS initiatives.
- Support Cost savings initiatives.

**This job might be for you if you have**:

- High School diploma required; college diploma preferred
- Agile, BPCS, Microsoft Office experience preferred, as well as previous experience with document control systems and Internal Auditing experience
- Strong computer skills required
- Medical Device Standard and Regulations knowledge is required for this position
- Working knowledge of quality system documentation requirem