1+ months

Sr. Manager, Quality Assurance

American Society of Civil Engineers
Redmond, WA

EndoGastric Solutions, Inc. is a fast-growth medical technology company headquartered in Redmond, Washington.  The company is revolutionizing the fields of upper gastroenterology diseases including gastroesophageal reflux disease (GERD) and other GI disorders.

 We currently have an opportunity for a Senior Manager of Quality Assurance to provide Quality System leadership in maintaining and improving the Company’s Quality Management System and play a key strategic role in regulatory compliance, Quality department management and developing/reporting Quality objectives and metrics.

 Responsibilities include the following activities:

  • Provide regulatory compliance experience/knowledge to facilitate resolution of quality management system issues
  • Serve as a focal point on Quality matters including CAPA and continual improvement activities in Operations
  • Serve as statistical resource in for Engineering and Operations
  • Supervise product complaint investigation activities
  • Manage Quality Engineering & Document Control departments
  • Present quality metrics to executive management during management review meetings
  • Overall responsibility for the effectiveness and compliance of the Quality Management System including the Quality Policy and Quality Manual

  • BSME or equivalent experience in a medical device environment
  • Thorough knowledge of 21CFR820 Quality System and ISO13485:2016 Regulations
  • Fifteen or more years of Quality Engineering experience in a medical device manufacturing environment
  • Minimum seven years management experience in Quality Assurance
  • Experience with both Supplier Management and WIP quality processes
  • Experience hosting FDA inspections and ISO Notified Body audits
  • Proficiency generating/revising tier-two/three quality system documents
  • Experience with generating risk management reports
  • Excellent written and verbal communication skills including ability to communicate technical information
  • Thorough knowledge of quality and reliability design principles
  • Experience with sterile disposable devices
  • Proficiency in product data analysis and trend reporting
  • Preference for Certified Quality Engineer (CQE)


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Sr. Manager, Quality Assurance

American Society of Civil Engineers
Redmond, WA

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Sr. Manager, Quality Assurance

American Society of Civil Engineers
Redmond, WA

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