Quality Systems Co-op

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. 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, procedu…

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