Quality Engineer

ZOLL Medical Corporation-posted 4 months ago
Full-time
Deerfield, WI
Merchant Wholesalers, Durable Goods
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At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions. The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service. At ZOLL, you won't just have a job. You'll have a career—and a purpose. Join our team. It's a great time to be a part of ZOLL!

  • Performs a variety of complex tasks related to Quality Assurance including performing trend analyses on quality data to provide early warning of potential problems and improvement opportunities.
  • Develop, implement, and manage value improvement projects which incorporate a Lean/Six-Sigma approach.
  • Perform analyses on quality information to proactively improve potential problems and capture improvement opportunities including non-product software.
  • Performs internal quality audits and effectiveness reviews (FDA's QSR, ISO 13485, MDD, CMDR).
  • Conducts supplier evaluations and audits.
  • Responsible for the development and execution of Lean/six-Sigma and other cost improvement initiatives that can be related to product quality.
  • Responsible to understand the appropriate legal and regulatory requirements in the areas of medical device operations and to establish robust processes and controls to ensure compliance.
  • Responsible to build and improve key business relationships within the organization's cross functional departments.
  • Ensure operations quality measurement systems are capable (Gauge R&R), process capability (Cpk) is high and process controls are in place to assure that products meet specifications.
  • Ensure that equipment is calibrated and maintained in accordance with requirements, and that these activities are properly documented.
  • Conducts various risk analysis activities for new and existing products including FMEAs and Fault Tree Analyses.
  • Prepare, submit and coordinate the process validation requirements for non-product software validations.
  • Participates in the FDA premarket approval process (PMA) for new and modified medical devices.
  • Participates in the nonconforming material/Material Review Board process.
  • Championing the implementation of Lean Manufacturing processes.
  • Participate in Kaizen events as a representative of the quality department.
  • Requires a BS degree or equivalent experience in a technical or scientific discipline.
  • Experience in an FDA regulated Class III electrical medical device manufacturing environment required.
  • Experienced in process development and validation for electro-mechanical assembly, test, and service required.
  • Formal Project management experience a plus preferred.
  • Lean experience preferred.
  • Experience with database queries and reporting in SQL or Microsoft Access preferred.
  • Six Sigma Green Belt Certification Preferred.
  • Black Belt Preferred.
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