29 Aug
|
Sonova Group
|
Ontario
29 Aug
Sonova Group
Ontario
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At Sonova, we envision a world where everyone can enjoy the delight of hearing. This vision inspires us and fuels our commitment to developing innovative solutions that improve hearing health and human connection - from personal audio devices and wireless communication systems to hearing aids and cochlear implants. We're dedicated to providing outstanding customer experiences through our global audiological care services, ensuring that everyone has the opportunity to engage fully with the world around them.
Guided by a culture of continuous improvement that fosters resilience and self-motivation, our team is united by a shared commitment to excellence and a deep sense of pride in our work, each of us playing a vital role in creating meaningful change,
Here you’ll find a diverse range of opportunities that span both consumer and medical solutions and the freedom to shape your career while making an impact on the lives of others. Join us in our mission to create a more connected world, where every voice is heard and every story matters.
Manufacturing Engineering Quality Assurance Manager
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:
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.
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 Outstanding 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.
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📌 Manufacturing Engineering Quality Assurance Manager (Ontario)
🏢 Sonova Group
📍 Ontario