Design Quality Engineer

Verathon; British Columbia; On-site; CAD 78,000 - 103,000; Full time

Benefits offered by this job

Competitive benefits package

Annual bonus plan

Paid holidays and time off

Retirement matching plan

Job summary

A healthcare technology innovator based in British Columbia is seeking a Design Quality Engineer II to support quality aspects of new product development. The ideal candidate will have a solid background in quality engineering within the medical devices sector and a Bachelor’s degree in Engineering. Responsibilities include risk management, compliance testing, and driving product lifecycle quality. Competitive salary and benefits included.

Qualifications

• Minimum of 3 years of experience in quality engineering.
• Familiarity with design control processes and risk management methodologies.
• Knowledge of relevant regulatory standards (ISO, FDA).

Responsibilities

• Develop and implement robust quality plans and risk management strategies.
• Review and approve validation protocols and reports.
• Partner with product development teams to execute design control.
• Define compliance testing requirements aligned with standards.
• Collaborate with teams to create and maintain Failure Modes and Effects Analyses.
• Drive product success through new product development support.
• Lead comprehensive product failure investigations and CAPA initiatives.
• Produce compliant documentation for risk and quality data.

Skills

Quality Management

Risk Management

Problem-solving

Statistical Analysis

Communication

Education

Bachelor's degree in Engineering

Master's degree in Engineering (preferred)

Job description

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

• Quality & 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.
• Validation Leadership: 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.
• Cross-Functional Collaboration: 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.
• Compliance Testing Excellence: Define and champion compliance testing requirements aligned with national and international quality and conformity standards, promoting teamwork and consistency across departments.
• Failure Mode Analysis: 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.
• Product Lifecycle Ownership: Drive product success by supporting new product development, leading design transfer to manufacturing, and bolstering sustaining engineering efforts throughout the product lifecycle.
• Quality Management System Enhancement: Continuously improve the Quality Management System to strengthen quality assurance processes and ensure compliance with Canadian and international standards.
• Failure Investigations & CAPA Leadership: Lead comprehensive product failure investigations and spearhead Corrective and Preventive Action (CAPA) initiatives to resolve issues and prevent recurrence.
• Documentation Excellence: 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.
• Cybersecurity Innovation: Establish and refine cybersecurity protocols, including product-related security risk assessments, in close collaboration with the software development team to ensure robust protection.
• Experimental Design & Reliability: Design and conduct strategic experiments to deepen insights into component and supplier process reliability, driving continuous improvement.

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, or a related field). A Master’s degree is a plus.
• Professional Engineer (P.Eng) or Engineer-in-Training (EIT) eligibility required.
• Minimum of 3 years of experience in quality engineering, particularly in medical devices or related fields.
• Familiarity with design control processes, risk management methodologies, and quality management systems.
• Knowledge of relevant regulatory standards (ISO, FDA) is essential.
• Strong analytical and problem-solving skills, with proficiency in statistical analysis.
• Excellent verbal and written communication skills to effectively collaborate with cross-functional teams.
• Certifications: Relevant certifications (e.g., CQE, CQA) are a plus.

Salary range - CAD $78,000.00 Annually - CAD $103,000.00 (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.

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

Verathon is an equal opportunities employer and welcomes applications from diverse candidates.