Kitchener, CanadaManufacturing 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:• 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
More about you:• 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
• Knowledge of ISO 13485, ISO 9001, MDR 2017/745, 21 CFR 820, and MDSAP required
• Experience with design transfer, process validation, nonconforming product, and CAPA processes preferred
• Strong 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.
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
- 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.
