Quality Systems Co-op

Location: YOW B, Canada

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Acquires further qualification for a Bachelor's degree, and gathers respective working experience in different administrative fields of expertise, in the course of a respective assignment.Under the direction of a QA/RA/EHS Leader, the QA Coordinator provides support of Epocal’ s Quality Management System (QMS) and Environmental, Health and Safety Management System (EHSMS). The QA Coordinator works to support Quality Assurance Operations, Quality Systems, Regulatory Affairs, QC Incoming Inspection, and Environment, Health and Safety as a support specialist. The QA Coordinator will be responsible for supporting the departments with a variety of technical and administrative tasks to support the ongoing compliance of the QMS.

The QA Coordinator (Co-Op) is based on site in Ottawa, ON. Siemens Healthineers Ottawa (SHS Ottawa) is a leading manufacturer of a clinical Point of Care (POC) diagnostic product. The epoc© Blood Analysis System is healthcare’s first cost-effective POC testing solution to leverage Smartcard Technology and wireless communication to provide caregivers with real-time, lab-quality blood gas, electrolyte, and metabolite results at the patient bedside.

The QA/RA/EHS Organization is responsible for various activities, supporting the manufacture of In-Vitro Medical Devices. We work collaboratively across the manufacturing site with Engineering, Operations and Procurement groups to ensure compliance with:

ISO 13485, ISO 14001, ISO 45001

FDA Quality System Regulation,

Health Canada Medical Device Regulations and,

Other international requirements as applicable, e.g., IVD Regulation for CE Marking.

Under the direction of a QA/RA/EHS Leader, the QA Coordinator provides support of Epocal’ s Quality Management System (QMS) and Environmental, Health and Safety Management System (EHSMS).  The QA Coordinator works to support Quality Assurance Operations, Quality Systems, Regulatory Affairs, QC Incoming Inspection, and Environment, Health and Safety as a support specialist.  The QA Coordinator will be responsible for supporting the departments with a variety of technical and administrative tasks to support the ongoing compliance of the QMS.

Duties and Responsibilities

Routine Duties

Support with data entry, Task Automation and Database Management of QA/RA/EHS activities

Assists with the review of Standard Operating Procedures (SOPs) and records for entering into the electronic document management system, while following Good Documentation Practices

Assist with the organizing, preparation and presentation of basic Quality and Health and Safety Training

Assists with coordination and trending of Quality System metrics.

Assists in conducting periodic review to ensure compliance with established standards (This includes evaluating processes, procedures, and documentation to identify any areas where improvements or corrective actions may be needed).

Assist in preparing for the management review by compiling relevant information, data, and metrics related to the organization's quality performance. This may include creating slides or presentations, drafting meeting minutes, and following up with actions after the review.

Assist in the change process. This includes identifying and analyzing proposed changes, assessing their potential impact on quality, and working with the relevant departments or teams to implement the changes effectively.

Assist in the audit preparation process. This includes helping to ensure that all necessary documentation is available and up to date.

Assist in the training of employees on quality assurance policies, procedures, and processes.

Assist with tasks such as document creation, revision, and approval workflows within the Documentum system.

Other duties as assigned by the Quality Assurance Manager

Note: Duties are not limited to those listed above. Additional duties may be assigned as required. However, reasonable accommodations will be made if all possible under business conditions.

Key Contacts

The Quality Assurance Coordinator may work with other departments or teams within the organization to gather information and identify opportunities for improvement. The ultimate goal is to ensure that the organization is operating at the highest level of quality, and that all products, processes, and services meet or exceed customer expectations.

Reports to the QA Systems Manager

Regular interaction across all departments

Job Demands

Juggling and prioritizing multiple tasks within a dynamic work environment

Ensuring compliance while meeting business objectives

Good communication & interpersonal skills to function effectively in a highly multidisciplinary team.

Strong organizational skills, self-management, time management skills

Self-starter and can work independently on projects as required.

Physical lifting of materials up to 15 lbs.

Extended periods of sitting/computer use

Skills & Qualifications (Education and Experience)

Student enrolled in a college or University Degree program (preferably BSc or Engineering) and/or an equivalent combination of education and experience acceptable to Epocal.

Software skills are considered an asset (Task Automation)

Moderate level of computer literacy including MS Office (i.e., Word, Excel, PowerPoint) SharePoint, Flowcharting software, Acrobat, etc.

Ability to work independently as well as part of a team.

Willingness to learn and take on new responsibilities.

Demonstrate ability to take initiative and continuously improve.

This is a great opportunity for a student to gain hands-on experience in the fie