Overview
Verathon is a leading provider of innovative laryngoscopy and endoscopy products. We are committed to enhancing patient care through advanced medical technologies. Join our dynamic team in Burnaby, British Columbia, and contribute to our mission of delivering quality healthcare solutions.
As a Design Quality Engineer II, you will play a crucial role in supporting the quality aspects of new product development and sustaining engineering initiatives. You will work closely with cross-functional teams to ensure that all quality standards are met throughout the product lifecycle.
Responsibilities
Risk Management:
Proactively develop and implement robust quality plans, risk management strategies, risk management reports, system risk assessments (SRA), software risk assessments, and cybersecurity risk assessments to ensure compliance and mitigate potential issues.
Rigorously review and approve validation protocols and reports for design verification and validation activities (IQ, OQ, PQ), driving adherence to internal procedures and regulatory standards.
Actively partner with product development engineering and core teams to identify, communicate, and execute design control and risk management deliverables, fostering seamless collaboration across multiple projects.
Define and champion compliance testing requirements aligned with national and international quality and conformity standards, promoting teamwork and consistency across departments.
Collaborate closely with systems and design engineering teams to create, maintain, and enhance Failure Modes and Effects Analyses (uFMEA and dFMEA) to proactively address risks.
Drive product success by supporting new product development, leading design transfer to manufacturing, and bolstering sustaining engineering efforts throughout the product lifecycle.
Continuously improve the Quality Management System to strengthen quality assurance processes and ensure compliance with Canadian and international standards.
Lead comprehensive product failure investigations and spearhead Corrective and Preventive Action (CAPA) initiatives to resolve issues and prevent recurrence.
Produce high-quality, compliant documentation, including risk reports, verification and validation test reports, statistical analyses of experimental and quality data, receiving inspection requirements, and post-market surveillance plans.
Establish and refine cybersecurity protocols, including product-related security risk assessments, in close collaboration with the software development team to ensure robust protection.
Design and conduct strategic experiments to deepen insights into component and supplier process reliability, driving continuous improvement.
Qualifications
Relevant certifications (., CQE, CQA) are a plus.
Salary range - CAD $78,000.00 Annually - CAD $ (Compensation will vary based on skills, experience and location; it is not typical to be hired at or above the top of the salary range).
Full-time employees who are not on a commission plan are eligible for Verathon’s annual bonus plan based on company and individual performance.
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