Quality Engineer, Magog

**BETTER MOBILITY FOR LIFE** Savaria is a global leader in accessibility and patient care products, designing and building wheelchair lifts, stairlifts, elevators for home and commercial applications, medical beds, therapeutic surfaces, ceiling track lifts and patient slings. Savaria employs 2,450 valued associates globally and has 11+ manufacturing facilities to reach markets in North America, Europe, Australia, and Asia. **SAVARIA PATIENT CARE** Built from a heritage of brands including Span, Handicare and Silvalea, Savaria Patient Care provides products designed for safe patient handling and positive outcomes. Our research and clinically based product portfolio include therapeutic surfaces for pressure management and positioning, a complete range of innovative ceiling and floor lifts and slings. Savaria Patient Care is a division of Savaria Corporation, a global leader in accessibility. **Position Summary** This role is a dynamic opportunity within the Patient Care division, based at one of our manufacturing sites focused on patient lifter products in Magog, Quebec. The location also serves as the heart of our Design and Development Centre, where innovation meets production. Specializing in Class I medical devices, that are designed to significantly enhance mobility and improve the quality of life for individuals. These life-changing devices are distributed worldwide, playing a vital role in homecare and hospital environments, making a meaningful impact on people’s lives worldwide. Main roles - Ensuring the Quality Management System is maintained, continuously improved, and aligned with other Patient Care sites. - Monitoring and measuring site performance using meaningful KPIs to drive actionable improvements. - Actively engaging in daily operations alongside engineering and manufacturing teams. - Implementing proactive measures with suppliers to sustain and enhance their performance and quality standards. **Responsibilities** - Collaborate with R&D, Engineering and manufacturing teams to determine product/component quality specifications and establish means to ensure these are consistently meet. - Supervise QA Inspectors/Technicians for receiving, in-process, and finished device acceptance based on a Statistical Process Control Program. - Administer the audits program (quality and supplier), the corrective/preventive actions and ensure the effectivity of the taken actions. - Maintain QA files (product registrations, Technical Files) and assist with quality records and documents control management. - Coordinate the equipment calibration and preventive maintenance program. Train employees on instrumentation. - Coordinate Engineering Change from engineering to manufacturing (new and existing products), ensuring all activities are documented and outputs are compliant with regulatory requirements and other internal requirements. - Assist with product investigations, customer complaints, and service requests to understand failure modes and actions required. - Conduct trend analysis, develop and maintains KPI. - Improving monitoring tools and systems in place **Mindset, Skills & Education** - Energetic, eager, tenacious! - Bachelor’s degree in engineering, Health Science, or related field preferred; 5+ years of Quality Engineer or Medical Device Regulatory experience required if degree is not in a relevant field. - Experience in the medical device industry preferred. - Proficient in basic statistical analysis, root cause analysis, gauge validation, and calibration. - Strong understanding of auditing systems; able to work independently and demonstrate mechanical aptitude. - Skilled in developing and maintaining ISO 13485, MDSAP, and 21 CFR 820 compliant processes; capable of leading projects and training internal auditors. - Experienced in utilizing Failure Mode and Effects Analysis (FMEA) and driving improvement opportunities. - Committed to company safety policies and procedures; able to develop, deliver, and measure training as needed. This is an excellent opportunity for an ambitious, career-oriented individual desirous of being part of a large, evolving, and successful global organization with the ability to impact future success. This role is a chance to shape your career and the future of Savaria! Join us! Savaria provides equal employment opportunities and consideration to all qualified employees and applicants, including disabled individuals and veterans.