Quality Engineer
Top Benefits
About the role
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 .
Verathon® is looking for a Quality Engineer III to become the newest member of our Quality Assurance Team located in Burnaby, BC Facility. The Quality Engineer III has direct responsibility for Production Quality activities across the manufacturing value stream.
Responsibilities
- Take Charge of Quality Issues: Lead containment, investigation, and resolution of product quality issues with precision and urgency. Own and drive formal Corrective and Preventive Actions (CAPA) to eliminate root causes.
- Command Material Review Board (MRB): Spearhead MRB activities to investigate and disposition Non-Conforming Material (NCM), ensuring swift and decisive outcomes.
- Drive Supplier Accountability: Deliver clear, actionable non-conformance data to Supplier Quality Engineers (SQEs) to address deficiencies in supplied parts.
- Champion Quality Inspections: Provide hands-on engineering support for Incoming, In-Process, and Final Release inspections. Interpret requirements, align on risk, and boldly initiate, justify, and route changes to product requirements and procedures.
- Tackle Out-of-Tolerance (OOT) Challenges: Investigate and assess product impacts from OOT conditions tied to gauge/equipment calibration, ensuring robust solutions.
- Author and Own Validation Protocols: Write and review validation protocols and reports (IQ, OQ, PQ) to ensure compliance with internal procedures and regulatory standards.
- Shape Risk Management: Partner with Manufacturing Engineering to develop and maintain Process Failure Modes and Effects Analyses (PFMEA), proactively mitigating risks.
- Maintain Validation Excellence: Oversee the Master Validation Plan for all validated manufacturing processes, ensuring ongoing compliance and performance.
- Monitor and Improve Performance: Analyze production quality data (NCM trends, scrap, inspection turn times) and deliver bold recommendations to Quality and Operations leadership for continuous improvement.
- Ensure Lifecycle Compliance: Maintain product and process compliance throughout the product lifecycle, standing firm on quality standards.
- Bridge Design and Manufacturing: Collaborate with Design Quality and R&D Engineers to seamlessly transfer new product development into commercial manufacturing.
- Own Bioburden Monitoring: Coordinate and monitor bioburden activities to assess microbial contamination in finished products, ensuring compliance with cGMP and SOPs.
- Support Operations with Impact: Actively support the Operations team to resolve issues impacting quality and performance, driving operational excellence.
- Uphold the Quality Management System (QMS): Support and enhance Verathon’s Global QMS with a proactive, results-driven approach.
Qualifications
- Four-year technical degree (BS in Biomedical, Electrical or Mechanical Engineering preferred).
- Eligibility for EIT (Engineer In Training), or P. Eng. registration with EGBC.
- Minimum of 5 years of experience in the medical device industry with knowledge of FDA (QSR 21 CFR 820), ISO 13485, EU MDR and Health Canada requirements
- ASQ Certification preferred -- Certified Quality Engineer (CQE) / Certified Reliability Engineer (CRE)
- Experience with IEC 60601 Standards.
- Experience with verification and validation of products and processes.
- Experience with Quality Engineering tools such as sampling plans, GD&T, statistical process control (SPC), and FMEA required.
- Strong critical thinking and analytical problem-solving capability.
- Strong working knowledge of Power BI, Minitab or similar data analysis tools.
Salary range - $78,800 - $112,300 (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.
About Verathon
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 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, and has international subsidiaries in Canada, Europe and Asia. For more information, please visit www.verathon.com.
Quality Engineer
Top Benefits
About the role
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 .
Verathon® is looking for a Quality Engineer III to become the newest member of our Quality Assurance Team located in Burnaby, BC Facility. The Quality Engineer III has direct responsibility for Production Quality activities across the manufacturing value stream.
Responsibilities
- Take Charge of Quality Issues: Lead containment, investigation, and resolution of product quality issues with precision and urgency. Own and drive formal Corrective and Preventive Actions (CAPA) to eliminate root causes.
- Command Material Review Board (MRB): Spearhead MRB activities to investigate and disposition Non-Conforming Material (NCM), ensuring swift and decisive outcomes.
- Drive Supplier Accountability: Deliver clear, actionable non-conformance data to Supplier Quality Engineers (SQEs) to address deficiencies in supplied parts.
- Champion Quality Inspections: Provide hands-on engineering support for Incoming, In-Process, and Final Release inspections. Interpret requirements, align on risk, and boldly initiate, justify, and route changes to product requirements and procedures.
- Tackle Out-of-Tolerance (OOT) Challenges: Investigate and assess product impacts from OOT conditions tied to gauge/equipment calibration, ensuring robust solutions.
- Author and Own Validation Protocols: Write and review validation protocols and reports (IQ, OQ, PQ) to ensure compliance with internal procedures and regulatory standards.
- Shape Risk Management: Partner with Manufacturing Engineering to develop and maintain Process Failure Modes and Effects Analyses (PFMEA), proactively mitigating risks.
- Maintain Validation Excellence: Oversee the Master Validation Plan for all validated manufacturing processes, ensuring ongoing compliance and performance.
- Monitor and Improve Performance: Analyze production quality data (NCM trends, scrap, inspection turn times) and deliver bold recommendations to Quality and Operations leadership for continuous improvement.
- Ensure Lifecycle Compliance: Maintain product and process compliance throughout the product lifecycle, standing firm on quality standards.
- Bridge Design and Manufacturing: Collaborate with Design Quality and R&D Engineers to seamlessly transfer new product development into commercial manufacturing.
- Own Bioburden Monitoring: Coordinate and monitor bioburden activities to assess microbial contamination in finished products, ensuring compliance with cGMP and SOPs.
- Support Operations with Impact: Actively support the Operations team to resolve issues impacting quality and performance, driving operational excellence.
- Uphold the Quality Management System (QMS): Support and enhance Verathon’s Global QMS with a proactive, results-driven approach.
Qualifications
- Four-year technical degree (BS in Biomedical, Electrical or Mechanical Engineering preferred).
- Eligibility for EIT (Engineer In Training), or P. Eng. registration with EGBC.
- Minimum of 5 years of experience in the medical device industry with knowledge of FDA (QSR 21 CFR 820), ISO 13485, EU MDR and Health Canada requirements
- ASQ Certification preferred -- Certified Quality Engineer (CQE) / Certified Reliability Engineer (CRE)
- Experience with IEC 60601 Standards.
- Experience with verification and validation of products and processes.
- Experience with Quality Engineering tools such as sampling plans, GD&T, statistical process control (SPC), and FMEA required.
- Strong critical thinking and analytical problem-solving capability.
- Strong working knowledge of Power BI, Minitab or similar data analysis tools.
Salary range - $78,800 - $112,300 (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.
About Verathon
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 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, and has international subsidiaries in Canada, Europe and Asia. For more information, please visit www.verathon.com.