Manufacturing Engineering Quality Assurance Manager

Kitchener, Canada   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.  

Responsibilities:
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¢ Maintain and monitor QA activities and document control to ensure compliance with internal procedures and international regulations, including MDSAP and MDRâ€
¢ Support alignment with applicable standards and regulatory requirements, including ISO 13485, ISO 9001, FDA, and MDR 2017/745â€
¢ Collaborate with Manufacturing Engineering and Global Services teams on design transfer, process validation, FMEA, non-product software validation, and equipment qualification/verification activitiesâ€
¢ Support internal and external audit preparation, attendance, responses, evidence collection, and CAPA closure related to audit findingsâ€
¢ Trend and analyze OPS Key Performance Indicators to measure process effectiveness and recommend quality improvementsâ€
¢ Oversee evaluation and disposition of nonconforming products and processes, coordinating resolution with Quality Assurance, Reliability, Manufacturing Engineering, and Operationsâ€
¢ Coordinate CAPA activities, support root cause investigations, perform change control impact analysis, and assist with complaint handling documentation and resolution   More about you: â€
¢ Graduate degree in engineering, science, quality, or another technical field required; Bachelor’s degree considered an assetâ€
¢ 4+ years of experience in a medical device manufacturing environment within a quality-related roleâ€
¢ Knowledge of ISO 13485, ISO 9001, MDR 2017/745, 21 CFR 820, and MDSAP requiredâ€
¢ Experience with design transfer, process validation, nonconforming product, and CAPA processes preferredâ€
¢ Strong communication, presentation, stakeholder management, negotiation, and problem-solving skillsâ€
¢ Self-motivated, proactive, organized, reliable, and able to explain complex quality regulations to non-expertsâ€
¢ Advanced MS Office skills required; SAP R/3 or S/4, eQMS, ServiceNow, and Planisware experience preferred   Travel: 10% travel may be required.   Don't meet all the criteria?  If you’re willing to go all in and learn, we'd love to hear from you    We are looking forward to receiving your application via our online job application platform. For this position only direct applications will be considered. Sonova does not recruit via app, telegram, carrier pigeon or any other format that does not include speaking with an actual human. If you are offered a job without speaking with someone, please contact Sonova HR.  

What we offer
Exciting and challenging work environment  Collaborative culture  Opportunities for continuous self-improvement  Opportunities for flexible hybrid model work environment  A company that values diversity and inclusion  Rich benefits plan including wellness benefit, paramedical (massage therapist, naturopath, etc.) and competitive compensation including variable component and employer match on pension contributions  Mentorship program and career development plans    This role's pay range is between: $76,000 – 95,000 annually      Sonova 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.