Manufacturing Engineering Quality Assurance Manager

Sonova Group; Kitchener; Hybrid; CAD 76,000 - 95,000; Full time

Benefits offered by this job

Hybrid work model

Wellness benefits

Competitive compensation with pension

Mentorship program

Job summary

Sonova Canada is seeking a Manufacturing Engineering QA Manager to ensure end-to-end quality and regulatory compliance across Manufacturing Engineering and Services processes. You will lead QA activities, drive design transfer, process validation, CAPA, and change control in line with MDSAP and MDR requirements.

You will collaborate with cross-functional teams, support audits, monitor OPS KPIs, and oversee disposition of nonconforming products.

Qualifications

• Graduate degree in engineering or science required.
• 4+ years in a medical device manufacturing QA role.
• Knowledge of ISO 13485, ISO 9001, MDR 2017/745, 21 CFR 820, and MDSAP.
• Experience with design transfer, process validation, CAPA, nonconforming product handling.
• Strong communication and problem-solving skills.
• Advanced MS Office; SAP R/3 or S/4, eQMS, ServiceNow, and Planisware preferred.

Responsibilities

• Maintain QA activities and document control to ensure compliance with procedures and regulations (MDSAP, MDR).
• Align with standards and regulatory requirements (ISO 13485, ISO 9001, FDA, MDR).
• Collaborate on design transfer, process validation, nonconforming product handling, CAPA, and software validation.
• Support internal and external audit preparation, responses, and CAPA closure.
• Trend OPS KPIs to measure process effectiveness and drive improvements.
• Oversee disposition of nonconforming products and processes with QA, Reliability, ME, and Operations.
• Coordinate CAPA activities and assist with root cause investigations and change control impact analyses.

Skills

Communication skills

Presentation skills

Stakeholder management

Negotiation

Problem solving

Self-motivation

Education

Graduate degree in engineering or science

Bachelor's degree considered an asset

Tools

SAP R/3/S4

eQMS

ServiceNow

Planisware

MS Office

Job description

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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.

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 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.