Quality Systems Co-op

460w EPOCAL INC.; Ottawa; On-site; CAD 21,000 - 30,000; Part time

Benefits offered by this job

Accessibility accommodations

On-site work

Job summary

Siemens Healthineers Ottawa seeks a QA Coordinator Co‑op to support the Quality Management System and Environmental, Health and Safety Management System on-site in Ottawa, ON. You will assist QA/RA/EHS activities, document management, training, and metrics while working under the QA Systems Manager.

Responsibilities include data entry, SOP reviews, change management, audit prep, and preparing management review materials.

Qualifications

• Currently enrolled in a college or university degree program (BSc or Engineering preferred).
• MS Office, SharePoint and Flowcharting software proficiency.
• Ability to work independently as well as in a team.
• Willingness to learn and take on new responsibilities.
• Demonstrate initiative and continuous improvement mindset.

Responsibilities

• Support data entry, task automation and database management for QA/RA/EHS activities.
• Review SOPs and records for entry into electronic document management system per Good Documentation Practices.
• Organize, prepare and present basic Quality and Health and Safety training.
• Coordinate and trend Quality System metrics.
• Assist in periodic reviews to ensure compliance with established standards.
• Prepare management review materials, compile data, create slides, draft minutes, and follow up on actions.
• Assist in the change process by analyzing proposed changes and coordinating implementation.
• Assist in audit preparation ensuring documentation is up to date.
• Train employees on QA policies and processes.
• Handle Documentum workflows.
• Other duties as assigned.

Skills

Task Automation

MS Office

SharePoint

Flowcharting

Independence

Teamwork

Time management

Education

College/University Degree program (BSc or Engineering preferred)

Tools

SharePoint

MS Office Suite

Flowcharting software

Job description

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

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.

Responsibilities

• Support with data entry, Task Automation and Database Management of QA/RA/EHS activities.
• Assist 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.
• Assist with coordination and trending of Quality System metrics.
• Assist in conducting periodic review to ensure compliance with established standards (including 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, creating slides or presentations, drafting meeting minutes, and following up with actions after the review.
• Assist in the change process by identifying and analyzing proposed changes, assessing their potential impact on quality, and working with relevant departments or teams to implement the changes effectively.
• Assist in the audit preparation process by ensuring 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

• 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.

Benefits & Accommodations

• Reasonable accommodations will be made under business conditions.
• Accessibility: Siemens Healthineers is committed to excellence in serving all employees and customers, including people with disabilities. It will strive to ensure policies and procedures established with respect to the provisions of its goods and services to persons with disabilities are consistent with the principles of dignity, independence, integration and equal opportunity as provided in the Accessibilities for Ontarians with Disabilities Act, 2005.
• The company will continue to attempt to meet the needs of all its customers, including but not limited to persons with disabilities, in an effective and timely manner.
• We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed.

About the Company

Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision‑making and treatment pathways.

How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Equal Employment Opportunity Statement

Siemens Healthineers is committed to creating a diverse environment and is proud to be an equal opportunity employer. While we appreciate all applications we receive, we advise that only candidates under consideration will be contacted.

Accessibility Statement

Siemens Healthineers will strive to ensure policies and procedures established with respect to the provisions of its goods and services to persons with disabilities are consistent with the principles of dignity, independence, integration and equal opportunity as provided in the Accessibilities for Ontarians with Disabilities Act, 2005.