Location: Gananoque, Ontario
Posted: November 26th 2017
Deadline: January 25th, 2018
Cardinal Health Canada is currently seeking a Quality Specialist for an immediate need within our Gananoque facility. The primary purpose of this position is administration of change control, to support creation and approval of material specifications and maintain design history files. Other responsibilities include:
- creating and managing artwork for all products manufactured in the facility,
- supporting the change control process providing guidance to project leaders and assisting with approvals and document change
- document control,
- assisting with revising quality system procedures,
- electronically route for approval in Agile, and
- support the management of the quality management system.
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.
Coordinate CDPs and Quality Plans
- Review all pertinent information required to route the CDP through the system for approvals
- Maintain an active database of all relevant CDPs and quality plans on a shared drive.
- Confirm information from all the actions required on quality plans for each CDP
Change Analyst – CDP’s
- Facilitating the management of CDP projects and statuses ensuring all appropriate information is added as required (attributes, affected items, attachments, etc.);
- Reviewing CDP Plan to ensure all deliverables are identified;
- Routing for review planning approvals; ensuring that all deliverables identified in the plan-summary and implementation worksheets are related/attached to support the objective evidence;
- Ensuring change orders are at the appropriate status and on the relationships tab;
- Routing for review evaluation approvals.
- Support the development and maintenance of documentation for raw materials,
- Finished good specifications (BOMS) in the current operating system (Agile/BPCS)
- Review and route raw material and finished good records for all new raw material and products in the Agile/BPCS system
- Maintain records for all raw materials and finished goods in Agile/BPCS system
Support Preparation of RMPS for Raw Material, Sub-Assembly, Finished Good and related Drawings
- Support creation of new and/or revise current component specifications ensuring documents contain the material specifications, tolerances, vendor information and testing references in the Agile system
- Support creation of new and/or revise current bill of materials documentation for subassemblies and finished products to include notes specific to the manufacture of the item and reference all documents required to start-up, manufacture, monitor, test and release the product
- Support creation and updating of engineering drawings of products or components using Solid Edge
- Responsible for ensuring the proper format is used, assigning control numbers and circulating electronically for the appropriate internal and external approvals
Change Analyst – Change Orders/Change Control
- Review all facility CO’s (Change Orders) in Agile for all document and part object changes including all CO’s submitted by tech services (RMPS’s and part object changes), add the appropriate approvers to each CO as per corporate approval matrix and route all CO’s in the Agile electronic system for approvals.
- Make all facility CO’s effective (push to completion phase) in the Agile electronic system once CO’s have been fully approved.
- Maintain the (QSMDL) Quality System Master Document List access database.
- Print, copy, scan, upload pdfs’s and distribute (hard copy or electronically) all documentation changes as per QSMDL distribution.
Packaging Graphics Coordinator
- Coordinate both new designs and revisions to packaging and labelling artwork files working with marketing representatives, internal personnel as well as external customers, often using Adobe InDesign and/or Adobe Illustrator
- Coordinate implementation into production with purchasing/planning personnel and manufacturing resources
- Creation of labelling used for the packaging and shipping of finished product.
Design History Files/Technical Files
- Produce and maintain design history files, device master records and technical files for the Gananoque manufactured finished goods in Kendall branded, private labeled and OEM specified product categories
- Create design history files for product families, when applicable
- Work with relevant parties/teams to collect and compile data
- Maintain index for the CDP process to afford easy review and audit of the files
- High school diploma or equivalent
- Experience with graphic design, artwork management
- Familiarity with BPCS and Agile systems
- Must be proficient in the use of MS Office, including Word, Excel, Access, and MS Project etc.
- Ability to take on projects, and follow through with minimal supervision
- Ability to read, write and speak English
- Excellent interpersonal and communication skills
Cardinal Health is committed to employment equity and encourages applications from women, visible minorities, Aboriginal peoples and persons with disabilities.
Cardinal Health is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Gananoque, Ontario, Canada
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