Step into a leadership position as Design Quality III in Montreal, guiding design assurance for a crucial medical device within the Electrophysiology domain. This hybrid role stresses the importance of collaboration and risk management.
As a key player, you will be responsible for leading design control and integration efforts for Capital Equipment while working closely with diverse teams. Your role will involve the creation and maintenance of comprehensive risk management files to ensure the highest safety and compliance standards. You will serve as the primary consultant for design assurance during audits and inspections, influencing quality-focused decisions.
Key Responsibilities:
• Serve as the technical authority in design assurance
• Oversee rigorous risk management and design verification
• Collaborate with R&D, regulatory, and clinical stakeholders
• Conduct root cause investigations and CAPA resolutions
• Drive continuous improvement initiatives in design ...