Senior Product Quality Assurance Engineer
1 day ago
About Us
Verathon is a global medical device company dedicated to delivering high-quality products that improve patient care and outcomes. Our innovative solutions address unmet needs in the healthcare industry, making us a leader in bladder volume measurement and airway management.
Our Mission
We strive to be the trusted partner for our customers, providing effective support and guidance throughout the product lifecycle. Our team of experts collaborates closely to ensure seamless design transfer, manufacturing, and sustaining engineering.
Salary Range
The estimated annual salary for this role is $80,000 - $100,000, depending on experience and qualifications. In addition to a competitive salary, full-time employees are eligible for Verathon's annual bonus plan and comprehensive benefits package.
Job Responsibilities
- Support product lines from new product development through design transfer to manufacturing and sustaining engineering.
- Collaborate with cross-functional teams to identify, communicate, and execute or support execution for all design control and risk management deliverables.
- Define compliance testing requirements to applicable national and international quality and conformity standards and regulations.
- Maintain an effective Quality Management System, ensuring compliance to various Canadian and International Standards.
- Perform product failure investigations and other CAPA related activities.
- Analyze mechanical and electrical assemblies for tolerances.
- Produce compliant documents, including risk reports, verification, and validation test reports.
- Design and conduct experiments to develop knowledge on component and supplier process reliability.
Required Skills and Qualifications
- Bachelor of Science or Engineering Technology degree required; Electrical, Mechanical, or Biomedical discipline preferred.
- Minimum 3 years' experience with a Bachelor of Science Degree; Minimum of 1 year experience with Master Degree.
- Experience in a QA function is required; Medical device industry preferred.
- Engineer in Training (EIT) from the EGBC preferred.
- ASQ Certification, such as Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE) is preferred.
- Familiarity with FDA, Health Canada, EU MDR, PMDA, SFDA medical device regulations, standards, and guidance documents.
Benefits
- Competitive salary range: $80,000 - $100,000 per annum.
- Full-time employees are eligible for Verathon's annual bonus plan and comprehensive benefits package.
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