Verathon, Inc.

Design Quality Engineer III

Job ID 2024-1208
Category
Quality Assurance/Regulatory Affairs
Work Model
Onsite

Company Overview

Verathon is a global medical device company focused on supporting customers by being their trusted partner, delivering high-quality products that endure over time and ensure clinical and economic utility. Two areas where Verathon has significantly impacted patient care, and become the market leader in each, are bladder volume measurement and airway management. The company’s BladderScan portable ultrasound and GlideScope video laryngoscopy & bronchoscopy systems effectively address unmet needs for healthcare providers and meaningfully raise the standard of care for patients. Verathon, a subsidiary of Roper Technologies, is headquartered in Bothell, Washington, USA and has international subsidiaries in Canada, Europe and Asia Pacific. For more information, please visit www.verathon.com.

Overview

Verathon® is looking for a Design Quality Engineer to become the newest member of our QA/RA Team located in Burnaby, British Columbia.

 

The Design Quality Engineer is responsible for providing quality input and support for new product development and sustaining engineering.

Responsibilities

• Support product lines from new product development through design transfer to manufacturing and sustaining engineering
• Collaborate with the product development engineering team and product core teams to identify, communicate, and execute or support execution for all design control and risk management deliverables to VMCA projects
• Define compliance testing requirements, to applicable national and international quality and conformity standards and regulations for VMCA products in collaboration across teams
• Support Quality Management System that establishes and maintains effective quality assurance processes and compliance to various Canadian and International Standards
• Perform product failure investigations and other CAPA related activities
• Perform tolerance analysis on mechanical and electrical assemblies
• Produce compliant documents like risk reports, verification, and validation test reports to the company, pertaining to design, manufacturing, service, including statistical analysis of experimental, test and quality data
• Define Cyber Security protocols including security risk assessments as related to VMCA products in collaboration with software development team.
• Design and conduct experiments and tests to develop a body of knowledge on component and supplier process reliability

Qualifications

• Bachelor of Science or Engineering Technology degree is required; Electrical, Mechanical, or Biomedical discipline preferred
• 5+ years of work experience in a QA function is required; Medical device industry preferred
• ASQ Certification, such as Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE) is preferred
• Experience within the medical device industry with knowledge of FDA, Health Canada, EU MDR, PMDA, SFDA medical device regulations, standards, and guidance documents (QSR 21 CFR 820, CMDR, MDD and ISO 13485, IEC 60601, ISO 10993, ISO14971,)
• Ability to effectively communicate both verbally and in writing and to apply critical thinking in problem identification and resolution

 

Salary range – CDN $88,240 - $123,467  (Compensation will vary based on skills, experience and location. If this position is filled outside the Greater Vancouver, BC area, this salary range will vary depending on the specific hiring location.) 

 

Verathon provides a competitive benefits package including a generous HCSA, paid holidays, paid time off and a retirement matching plan

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