Quality Assurance Engineer
Verathon - Bothell, WA

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Verathon is a wholly owned subsidiary of Roper Industries, an acquisitive S&P 500 and NYSE listed diversified growth company. Verathon is headquartered in the greater Seattle area, in Bothell, Washington, and has 7 international subsidiaries in Canada, Europe and Asia. The company designs, manufactures, distributes and markets reliable, state-of-the-art medical devices and services to the health care community that offer meaningful improvement in patient care. Our largest brands, Bladderscan and Glidescope, have achieved worldwide recognition as the number one leader in their respective markets. Verathon is a financially sound company with consistent growth and performance even during down market cycles. We have a strong pipeline of new products for multiple areas of discipline within the heath care industry. We offer an entrepreneurial environment that is team-centered, customer-driven, quality-focused, and growth-oriented. Working at Verathon gives you access to challenging, "stretch" opportunities. Verathon was acquired by Roper Industries in December 2009 as a platform for future acquisitions leveraging the talented management team and extraordinary channel development in developed country markets.

Summary:
Primary product line responsibilities from new product development through design transfer to manufacturing, and sustaining engineering

  • Defining Quality and engineering requirements for product design, and coordinating testing
  • Assuring products are adequate transferred into production including development and deployment of IQ, OQ, and PQ.
  • Maintaining product and manufacturing compliance throughout the life of the product
Principle Duties and Responsibilities:
  • Support Quality Management System that establishes and maintains effective quality assurance processes and compliance to the International Standard: ISO13485, Canadian Medical Device Regulations (CMDR, SOR 98-292), FDA Quality System Regulations (QSR, 21 CFR Part 820) and the Medical Device Directive (MDD93/42/EEC)
  • Provide reliability-related reports to the company, pertaining to design, manufacturing, service, including statistical analysis of experimental, test and quality data
  • Perform product Failure Investigations and other CAPA related activities
  • Design and conduct experiments and tests to develop a body of knowledge on component and supplier process reliability
  • Periodically conduct product and process validations
  • Participate and occasionally conduct Internal Audits
  • Perform tolerance analysis on mechanical and electrical assemblies
  • Clearly communicate any quality concerns to the Senior Regulatory Affairs and Quality Assurance Manager
  • Uphold the Verathon Company Mission and Quality Policy
Knowledge, Skills and Abilities:
  • ASQ Certification, such as Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE) is preferred
  • Technical degree (Electrical Engineer or Mechanical Engineer preferred)
  • Experience in product safety (IEC 60601 Standards) a plus
  • Experience with FDA 510(k) submissions, EU Technical Files, and defining global product regulatory requirements
  • Minimum of ten years experience in a medical device industry with in-depth knowledge of FDA, Health Canada, EU MDD medical device requirements (QSR 21 CFR 820, CMDR, MDD and ISO 13485)
  • Skill in analytical problem solving
  • Experience and aptitude in Design of Experiments
  • Ability to work under time constraints
  • Ability to prioritize effectively and focus on results
  • Ability to handle strong opposition is required
  • Professional interpersonal and communication skills
Verathon is an equal opportunity employer and strongly supports diversity in the workplace. We believe that diverse ideas, opinions and perspectives will build a strong foundation for success.

Verathon - 21 months ago - save job