Manufacturing Engineering Quality Assurance Manager

Sonova AG•Kitchener, ON

10d•CA$76,000 - CA$95,000•Hybrid

About The Position

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.

Requirements

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
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

Nice To Haves

Experience with design transfer, process validation, nonconforming product, and CAPA processes preferred
SAP R/3 or S/4, eQMS, ServiceNow, and Planisware experience preferred

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