Lead quality systems, CAPA, and regulatory compliance at Baylis Medical Technologies in a hybrid management role with flexible hours. Guide measurable improvement across medical device operations.
As Manager, Quality Assurance and Excellence, you will supervise qualified staff and direct quality-system effectiveness, compliance, analysis, and improvement. The scope includes Document Control, Training, CAPA, Complaints, Internal Audits, Recalls, Field Actions, and standards compliance. You will partner with Operations, Supply Chain, Manufacturing, Regulatory, R&D;, Sales, Engineering, and Production to implement sustainable improvements.
Key Responsibilities: Lead quality-system execution, maintenance, and continuous improvement
Establish and sustain risk-based CAPA processes
Oversee document control, training, complaints, audits, and recalls
Analyze quality metrics,



trends, risks, and recurring issues
Supervise, coach, and develop Quality Assurance staff
Requirements: Bachelor’s degree in Engineering, Science, or related technical discipline
Eight years’ progressive Quality Assurance, Systems, or Excellence experience
Five years’ medical device or regulated-industry experience
Five years’ manufacturing experience and two years’ leadership experience
Knowledge of FDA, ISO 13485, ISO 14971, and related regulations
Bring quality-system leadership, CAPA expertise, and regulatory judgment to strengthen Baylis Medical Technologies’ medical device operations.

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📌 Quality Assurance Systems Manager (Ontario)
🏢 Baylis Medical Technologies
📍 Ontario