Manufacturing Engineering QA ManagerSonova is seeking a Manufacturing Engineering QA Manager to ensure end-to-end quality and regulatory compliance across Manufacturing Engineering and Services processes. This role provides QA leadership and hands‐on expertise in design transfer, process validation, FMEA, nonconforming product disposition, CAPA, change control, audits, complaint handling, and QA-driven projects, with an emphasis on MDSAP and MDR compliance and strong operational quality metrics.Kitchener, CanadaResponsibilities:Maintain and monitor QA activities and document control to ensure compliance with internal procedures and international regulations, including MDSAP and MDRSupport alignment with applicable standards and regulatory requirements, including ISO 13485, ISO 9001, FDA, and MDR 2017/745Collaborate with Manufacturing Engineering and Global Services teams on design transfer, process validation, FMEA, non-product software validation, and equipment qualification/verification activitiesSupport internal and external audit preparation, attendance, responses, evidence collection, and CAPA closure related to audit findingsTrend and analyze OPS Key Performance Indicators to measure process effectiveness and recommend quality improvementsOversee evaluation and disposition of nonconforming products and processes, coordinating resolution with Quality Assurance, Reliability, Manufacturing Engineering, and OperationsCoordinate CAPA activities, support root cause investigations, perform change control impact analysis, and assist with complaint handling documentation and resolutionMore about you:Graduate degree in engineering, science, quality, or another technical field required; Bachelor's degree considered an asset4+ years of experience in a medical device manufacturing environment within a quality-related roleKnowledge of ISO 13485, ISO 9001, MDR 2017/745, 21 CFR 820,



and MDSAP requiredExperience with design transfer, process validation, nonconforming product, and CAPA processes preferredStrong communication, presentation, stakeholder management, negotiation, and problem‐solving skillsSelf-motivated, proactive, organized, reliable, and able to explain complex quality regulations to non-expertsAdvanced MS Office skills required; SAP R/3 or S/4, eQMS, ServiceNow, and Planisware experience preferredTravel: 10% travel may be required.This role's pay range is between: $76,000 – 95,000 annuallyWhat we offer:Exciting and challenging work environmentCollaborative cultureOpportunities for continuous self‐improvementOpportunities for flexible hybrid mode work environmentA company that values diversity and inclusionRich benefits plan including wellness benefit, paramedical (massage therapist, naturopath, etc.) and competitive compensation including variable component and employer match on pension contributionsMentorship program and career development plansSonova Canada is now a certified Great Place to Work May 2024- May 2025.How we work:At Sonova, we prioritize the well‐being of our employees and foster an inclusive environment that promotes engagement and collaboration. Our team‐customized hybrid work model empowers teams to balance individual needs with business goals, offering flexibility and individualized time management. We recognize the importance of life outside of work and strive to create a supportive and motivating workplace where innovation thrives.Sonova is an equal opportunity employer.We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate's ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.

📌 Manufacturing Engineering Quality Assurance Manager (Kitchener)
🏢 Sonova Group
📍 Kitchener