Manager, Design Quality Engineering

Verathon • Burnaby, BC

13d

About The Position

Verathon® is looking for a Manager, Design Quality Engineering to become the newest member of our Quality and Regulatory Team located in Burnaby, British Columbia. The Manager, Design Quality Engineering is responsible for ensuring product quality and compliance throughout the product development process from concept to commercial launch. The Manager, Design Quality Engineering will lead a team of skilled engineers in the application and enhancement of Design Control and Risk Management processes, ensuring project execution to achieve business goals and growth.

Requirements

• Bachelor’s degree in a related scientific or technical discipline is required; Masters preferred
• Typically requires a minimum of 5 years' experience in quality engineering or new product development within a regulated industry (e.g., medical devices, pharmaceuticals, biotechnology, or healthcare products).
• A minimum of 2 years of people management is required.
• Demonstrated proficiency and knowledge of current medical device Good Manufacturing Practices 21CFR820, FDA 510(k), and EU Medical Device Regulation.
• Must possess excellent leadership skills with ability to work effectively in cross-functional teams in a dynamic, fast-paced environment.
• Demonstrated ability to build, engage and develop a team to sustain a productive and positive working environment.

Nice To Haves

• Experience with IEC 60601, device cybersecurity, and/or sterile single-use devices desirable

Responsibilities

• Leads quality team on product development projects, executing functional deliverables and ensuring technical excellence in the achievement of organizational goals. Key Quality voice of influence on projects.
• Owns and drives deliverables related to Design Controls, Risk Management, Product Performance, Quality, and Compliance.
• Develops and implements quality strategies; seeks innovative approaches to attain quality goals.
• Drives functional excellence in Quality Engineering by developing, coaching, and mentoring team members.
• Maintains and enhances cross-functional team relationships.
• Provides significant guidance regarding technical strategies and approaches; works cross-functionally in identifying and resolving technical issues.
• Drives continuous improvement in enabling processes, especially Design Controls and Risk Management.
• Develops department budget and monitors spending. Works with key partners to understand priorities and plans resource allocation accordingly.
• Fosters a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Monitors and ensures compliance with company policies and procedures.
• Audit Mastery: Plan and execute detailed audits across various project phases to ensure compliance with Verathon standards and contract requirements. Manage follow-up activities for internal audits, ensuring corrective actions are effectively implemented.
• Must have the ability to travel to the US regularly without restrictions.

Benefits

• Competitive salary and comprehensive benefits package.
• Full-time employees who are not on a commission plan are eligible for Verathon’s annual bonus plan based on company and individual performance.
• Verathon provides a competitive benefits package including a generous HCSA, paid holidays, paid time off and a retirement matching plan.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 251-500 employees