Manufacturing Engineering QA Manager Sonova 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. Maintain and monitor QA activities and document control to ensure compliance with internal procedures and international regulations, including MDSAP and MDR Support alignment with applicable standards and regulatory requirements, including ISO 13485, ISO 9001, FDA, and MDR 2017/745 Collaborate with Manufacturing Engineering and Global Services teams on design transfer, process validation, FMEA, non-product software validation, and equipment qualification/verification activities Support internal and external audit preparation, attendance, responses, evidence collection, and CAPA closure related to audit findings Trend and analyze OPS Key Performance Indicators to measure process effectiveness and recommend quality improvements Oversee evaluation and disposition of nonconforming products and processes, coordinating resolution with Quality Assurance, Reliability, Manufacturing Engineering, and Operations Coordinate CAPA activities, support root cause investigations, perform change control impact analysis,



and assist with complaint handling documentation and resolution Graduate degree in engineering, science, quality, or another technical field required; Bachelor’s degree considered an asset ~4+ years of experience in a medical device manufacturing environment within a quality-related role ~ Robust communication, presentation, stakeholder management, negotiation, and problem‑solving skills ~ Self-motivated, proactive, organized, reliable, and able to explain complex quality regulations to non-experts ~ Advanced MS Office skills required; SAP R/3 or S/4, eQMS, ServiceNow, and Planisware experience preferred Travel: 10% travel may be required.

Opportunities for continuous self‑improvement Opportunities for flexible hybrid model work environment A company that values diversity and inclusion and competitive compensation including variable component and employer match on pension contributions 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. 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