Manager, Complaints and Post-Market

Noah Medical
San Jose, CA
Job Description
Noah Medical is seeking a skilled Quality Assurance Manager to oversee the Complaints and Post-Market team. This role involves handling complaints, investigating potential adverse events, managing regulatory reporting, and ensuring compliance with quality and regulatory requirements. The manager will work closely with various teams to maintain high product quality and ensure customer satisfaction.

Requirements

  • At minimum a BS degree in a technical field such as engineering, computer science, or a science related discipline.
  • 5+ years of complaint-handling experience in the medical device industry.
  • Working knowledge of the entire complaint handling process from intake, investigation, closure, and reportability assessments.
  • Strong Working knowledge of US FDA 21 CFR 820.198, 803, and 806 requirements.
  • Basic Working knowledge of OUS adverse event reporting requirements.
  • Basic working knowledge of OUS post market surveillance requirements.
  • Working statistical knowledge as it pertains to trending.

Benefits

  • Competitive salary
  • Comprehensive health insurance
  • Life Insurance
  • Disability insurance
  • Mental health support
  • Legal and Pet Insurance
  • Paid time off
  • Paid parental leave
  • In-office snacks and beverages
  • Learning & Development Opportunities
  • Team building and social events
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